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Review Panel
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Review Panel
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Review Panel
Hematology
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Immunology
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Microbiology
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Neurology
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Ophthalmic
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Orthopedic
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Pathology
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Physical Medicine
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Radiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
EAG
Cephalometer
2
Product Code
EAH
Cone, Radiographic, Lead-Lined
1
Product Code
EAP
Unit, X-Ray, Intraoral
2
Product Code
EHB
Collimator, X-Ray
1
Product Code
EHD
Unit, X-Ray, Extraoral With Timer
2
Product Code
MUH
System, X-Ray, Extraoral Source, Digital
2
Product Code
EAM
Screen, Intensifying, Radiographic
1
Product Code
EGT
Controller, Temperature, Radiographic
2
Product Code
EGW
Dryer, Film, Radiographic
2
Product Code
EGY
Processor, Radiographic-Film, Automatic, Dental
2
Product Code
HBK
Chair, Pneumoencephalographic
2
Product Code
ITX
Transducer, Ultrasonic, Diagnostic
2
Product Code
ITY
Assembly, Tube Housing, X-Ray, Diagnostic
1
Product Code
IWN
Cassette, Measurement, Ardran-Crooks
1
Product Code
IWY
Holder, Head, Radiographic
1
Product Code
IWZ
Film, Radiographic
1
Product Code
IXA
Cassette, Radiographic Film
2
Product Code
IXC
Illuminator, Radiographic-Film
1
Product Code
IXD
Source, Calibration, Sealed, Nuclear
1
Product Code
IXF
Test-Pattern, Radiographic
1
Product Code
IXG
Phantom, Anthropomorphic, Radiographic
1
Product Code
IXH
Camera, Focal Spot, Radiographic
1
Product Code
IXJ
Grid, Radiographic
1
Product Code
IXK
System, Imaging, X-Ray, Electrostatic
2
Product Code
IXL
Device, Spot-Film
2
Product Code
IXO
Synchronizer, Ecg / Respirator, Radiographic
1
Product Code
IXQ
Table, Radiographic, Stationary Top
2
Product Code
IXR
Table, Radiographic, Tilting
2
Product Code
IXW
Processor, Radiographic-Film, Automatic
2
Product Code
IXX
Processor, Cine Film
2
Product Code
IXY
Holder, Radiographic Cassette, Wall-Mounted
1
Product Code
IYB
Tube Mount, X-Ray, Diagnostic
1
Product Code
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
2
Product Code
IYO
System, Imaging, Pulsed Echo, Ultrasonic
2
Product Code
IYP
Phantom, Anthropomorphic, Nuclear
1
Product Code
IYQ
Phantom, Flood Source, Nuclear
1
Product Code
IYT
System, Rebreathing, Radionuclide
2
Product Code
IYW
Scanner, Rectilinear, Nuclear
1
Product Code
IYX
Camera, Scintillation (Gamma)
1
Product Code
IYY
Synchronizer, Electrocardiograph, Nuclear
1
Product Code
IYZ
Bed, Scanning, Nuclear
1
Product Code
IZC
Camera, Positron
1
Product Code
IZD
Probe, Uptake, Nuclear
1
Product Code
IZF
System, X-Ray, Tomographic
2
Product Code
IZG
System, X-Ray, Photofluorographic
2
Product Code
IZH
System, X-Ray, Mammographic
2
Product Code
IZI
System, X-Ray, Angiographic
2
Product Code
IZJ
Camera, X-Ray, Fluorographic, Cine Or Spot
2
Product Code
IZL
System, X-Ray, Mobile
2
Product Code
IZO
Generator, High-Voltage, X-Ray, Diagnostic
1
Product Code
IZP
Programmer, Changer, Film/Cassette, Radiographic
2
Product Code
IZS
Aperture, Radiographic
2
Product Code
IZT
Cone, Radiographic
2
Product Code
IZW
Collimator, Automatic, Radiographic
2
Product Code
IZX
Collimator, Manual, Radiographic
2
Product Code
IZZ
Table, Radiographic, Non-Tilting, Powered
2
Product Code
JAA
System, X-Ray, Fluoroscopic, Image-Intensified
2
Product Code
JAB
System, X-Ray, Fluoroscopic, Non-Image-Intensified
2
Product Code
JAC
System, X-Ray, Film Marking, Radiographic
1
Product Code
JAF
Monitor, Ultrasonic, Nonfetal
2
Product Code
JAG
Illuminator, Radiographic-Film, Explosion-Proof
1
Product Code
JAK
System, X-Ray, Tomography, Computed
2
Product Code
JAM
Scanner, Whole Body, Nuclear
1
Product Code
JAN
Counter, Whole Body, Nuclear
1
Product Code
JAO
Scanner, Fluorescent
2
Product Code
JAR
Phantom, Test-Pattern, Radionuclide
1
Product Code
JWM
System, Tomographic, Nuclear
2
Product Code
KGI
Densitometer, Bone
2
Product Code
KPR
System, X-Ray, Stationary
2
Product Code
KPS
System, Tomography, Computed, Emission
2
Product Code
KPT
Calibrator, Dose, Radionuclide
2
Product Code
KPW
Device, Beam Limiting, X-Ray, Diagnostic
2
Product Code
KPX
Changer, Radiographic Film/Cassette
2
Product Code
KXH
Cradle, Patient, Radiologic
1
Product Code
KXJ
Table, Radiologic
2
Product Code
LEK
Transilluminator (Diaphanoscope)
3
Product Code
LHO
Instrument, Quality-Assurance, Radiologic
1
Product Code
LLZ
System, Image Processing, Radiological
2
Product Code
LMA
Digitizer, Image, Radiological
2
Product Code
LMB
Device, Digital Image Storage, Radiological
1
Product Code
LMC
Camera, Multi Format, Radiological
2
Product Code
LMD
System, Digital Image Communications, Radiological
1
Product Code
LNH
System, Nuclear Magnetic Resonance Imaging
2
Product Code
LNI
System, Nuclear Magnetic Resonance Spectroscopic
2
Product Code
LQA
Media, Reusable Image
1
Product Code
MOS
Coil, Magnetic Resonance, Specialty
2
Product Code
MQB
Solid State X-Ray Imager (Flat Panel/Digital Imager)
2
Product Code
K
24
0371
0909FCC, 0909FCC-HS
2
Cleared 510(K)
K
23
2082
EXPD 4343S
2
Cleared 510(K)
K
23
2753
EXPD 4343D; EXPD 3643D
2
Cleared 510(K)
K
23
0918
MasterX 800 Series
2
Cleared 510(K)
K
23
2058
YosemiteView 4343W/YosemiteView 3643W
2
Cleared 510(K)
K
23
1959
EXPD 4357; EXPD 4357P
2
Cleared 510(K)
K
23
1709
AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4
2
Cleared 510(K)
K
23
1467
1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF
2
Cleared 510(K)
K
22
3930
A1417MCW/A1717MCW/F1417MCW
2
Cleared 510(K)
K
23
0175
Digital Radiography CXDI-CS01
2
Cleared 510(K)
K
23
0059
Digital Flat Panel Detector
2
Cleared 510(K)
K
22
3546
14HQ721G-B
2
Cleared 510(K)
K
22
3687
X-ray Flat Panel Detectors (EverestView 4343X)
2
Cleared 510(K)
K
22
3009
Wireless/Wired X-Ray Flat Panel Detectors
2
Cleared 510(K)
K
22
3124
EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
2
Cleared 510(K)
K
22
3267
SKR 3000
2
Cleared 510(K)
K
22
2886
Mercu 1717V
2
Cleared 510(K)
K
22
2855
Digital Radiography CXDI-Pro, Digital Radiography D1
2
Cleared 510(K)
K
22
2687
Digital Radiography CXDI-Elite, Digital Radiography E1
2
Cleared 510(K)
K
22
2661
Digital Radiography CXDI-CS01
2
Cleared 510(K)
K
22
0239
Solid State X-ray Imager(Model: FXRD-4386WB)
2
Cleared 510(K)
K
22
1549
X-ray Flat Panel Detectors (CareView 1800 RF)
2
Cleared 510(K)
K
22
1461
10HQ701G-B
2
Cleared 510(K)
K
22
1394
14HQ701G-B
2
Cleared 510(K)
K
22
1512
Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)
2
Cleared 510(K)
K
22
1876
Digital Radiography CXDI-Pro, Digital Radiography D1
2
Cleared 510(K)
K
22
1434
17HQ701G-B
2
Cleared 510(K)
K
22
1714
Flat Panel Detector
2
Cleared 510(K)
K
22
1345
Wireless Digital Flat Panel Detector
2
Cleared 510(K)
K
22
1620
Digital Radiography CXDI-Elite, Digital Radiography E1
2
Cleared 510(K)
K
22
1144
PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG
2
Cleared 510(K)
K
22
0559
17HQ901G-B
2
Cleared 510(K)
K
22
0536
Digital flat panel detector
2
Cleared 510(K)
K
22
0510
Yushan X-Ray Flat Panel Detector with DROC
2
Cleared 510(K)
K
22
0668
Wireless Digital Flat Panel Detector
2
Cleared 510(K)
K
21
3646
Focus HD 35 Detector
2
Cleared 510(K)
K
21
3529
Focus HD 43 Detector
2
Cleared 510(K)
K
21
4044
14HQ901G-B
2
Cleared 510(K)
K
22
0098
Digital Radiography CXDI-Pro, Digital Radiography D1
2
Cleared 510(K)
K
21
3908
SKR 3000
2
Cleared 510(K)
K
21
3780
DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1
2
Cleared 510(K)
K
21
4030
Universal DR 1748
2
Cleared 510(K)
K
21
3307
Eclipse II with Smart Noise Cancellation
2
Cleared 510(K)
K
21
3469
VALORY
2
Cleared 510(K)
K
21
3497
ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)
2
Cleared 510(K)
K
21
2753
0909FCB, 1212FCA
2
Cleared 510(K)
K
21
2269
Intelligent NR
2
Cleared 510(K)
K
21
2553
DIGITAL RADIOGRAPHY CXDI-Pro, D1
2
Cleared 510(K)
K
21
2051
RFA-1717DIG, RFA-1717DIC
2
Cleared 510(K)
K
21
0619
SKR 3000
2
Cleared 510(K)
K
21
2105
6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF
2
Cleared 510(K)
K
21
1790
DX-D Imaging Package with XD Detectors
2
Cleared 510(K)
K
21
1542
PRIMO S
2
Cleared 510(K)
K
21
1108
Prudent 1717, Prudent 1417, Prudent 1212
2
Cleared 510(K)
K
21
0919
AcuityDRe
2
Cleared 510(K)
K
21
0985
1717FCC
2
Cleared 510(K)
K
21
0988
Yushan X-Ray Flat Panel Detector with DROC
2
Cleared 510(K)
K
20
2441
Eclipse II with Smart Noise Cancellation
2
Cleared 510(K)
K
20
3703
I-Q View
2
Cleared 510(K)
K
20
3188
ADD
2
Cleared 510(K)
K
21
0316
Mars 1417X Wireless Digital Flat Panel Detector
2
Cleared 510(K)
K
21
0314
Mars1717X Wireless Digital Flat Panel Detector
2
Cleared 510(K)
K
20
2995
X-ray Flat Panel Detectors/CareView 3600RF
2
Cleared 510(K)
K
20
3849
General Radiography CXDI-CS01
2
Cleared 510(K)
K
20
3159
Lux 35 Detector
2
Cleared 510(K)
K
20
2722
1212FCA
2
Cleared 510(K)
K
20
1528
Yushan X-Ray Flat Panel Detector with DROC
2
Cleared 510(K)
K
20
2564
DigitalDiagnost C90
2
Cleared 510(K)
K
20
1591
Flat Panel Detector
2
Cleared 510(K)
K
20
1932
X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)
2
Cleared 510(K)
K
20
1796
1717SCV, 1717SGV
2
Cleared 510(K)
K
20
1503
Edge Air(1417) Digital Flat Panel X-ray Detector
2
Cleared 510(K)
K
20
1247
Intraoral Sensor
2
Cleared 510(K)
K
20
1043
Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)
2
Cleared 510(K)
K
20
1058
Accuvue+
2
Cleared 510(K)
K
20
1004
Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W
2
Cleared 510(K)
K
20
0787
BSD3543W
2
Cleared 510(K)
K
20
0668
DR-ID 1200SDK System
2
Cleared 510(K)
K
20
0622
Focus 43C detector, TRIMAX 43C detector
2
Cleared 510(K)
K
20
0418
VIVIX-S VW
2
Cleared 510(K)
K
19
2894
Vita Flex CR System with LLI
2
Cleared 510(K)
K
19
3644
E-COM DR-2000 DR
2
Cleared 510(K)
K
20
0018
HAD1717MC
2
Cleared 510(K)
K
19
3238
Nexus DR Digital X-Ray Imaging System (with vSharp)
2
Cleared 510(K)
K
19
3173
CareView 1800Le
2
Cleared 510(K)
K
19
3031
EXPD 4343P, EXPD 3643P
2
Cleared 510(K)
K
19
3017
EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP
2
Cleared 510(K)
K
19
2932
FDR D-EVO III flat panel detector system
2
Cleared 510(K)
K
19
2632
DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless
2
Cleared 510(K)
K
19
2440
FDR SE Lite
2
Cleared 510(K)
K
19
2512
Focus 35C Detector, Trimax 35C Detector
2
Cleared 510(K)
K
19
2400
EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG
2
Cleared 510(K)
K
19
1939
Yushan X-Ray Flat Panel Detector
2
Cleared 510(K)
K
19
1645
SKR 4000
2
Cleared 510(K)
K
19
0611
VIVIX-S 1751S
2
Cleared 510(K)
K
19
0691
Pixx2430 Digital Diagnostic X-Ray Receptor Panel
2
Cleared 510(K)
K
19
0368
Enhanced Feature Software Pack CXDI Series
2
Cleared 510(K)
K
19
0311
BIOK7600 Flat Panel Detector
2
Cleared 510(K)
K
19
0300
BIOK7600W Wireless Flat Panel Detector
2
Cleared 510(K)
K
19
0146
Nexus DR Digital X-ray Imaging System
2
Cleared 510(K)
K
18
3245
Carestream DRX-1 System with DRX Plus 2530 Detectors
2
Cleared 510(K)
K
18
3474
Carestream DRX-1 System with DRX Core Detectors
2
Cleared 510(K)
K
18
2973
DigitalDiagnost C90
2
Cleared 510(K)
K
18
3713
Wireless Digital Flat Detector
2
Cleared 510(K)
K
18
3422
Wireless Digital Flat Panel Detector
2
Cleared 510(K)
K
18
2688
SKR 3000
2
Cleared 510(K)
K
18
3286
17HK701G-W
2
Cleared 510(K)
K
18
3212
Nexus DR Digital X-ray Imaging System with stitching
2
Cleared 510(K)
K
18
2348
14HK701G-W
2
Cleared 510(K)
K
18
2551
Wireless Digital Flat Panel Detector
2
Cleared 510(K)
K
18
2550
Wireless Digital Flat Panel Detector
2
Cleared 510(K)
K
18
2533
PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels
2
Cleared 510(K)
K
18
1631
GR40CW
2
Cleared 510(K)
K
18
1565
Aquarius 8600 Digital Radiography Sensor
2
Cleared 510(K)
K
18
1526
XRpad2 4343 HWC-M Flat Panel Detector
2
Cleared 510(K)
K
18
0809
Eclipse II
2
Cleared 510(K)
K
18
0989
PEDRA-17F Digital Flat Panel X-ray Detector
2
Cleared 510(K)
K
18
0332
17HK700G-W
2
Cleared 510(K)
K
18
0976
PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels
2
Cleared 510(K)
K
18
1003
VIVIX-S 1717V
2
Cleared 510(K)
K
18
0667
SmartGrid
2
Cleared 510(K)
K
17
1270
DIGITAL RADIOGRAPHY CXDI-410C WIRELESS
2
Cleared 510(K)
K
17
3273
Aquarius 8600 1417WCI; Aquarius 8600 1717WCI
2
Cleared 510(K)
K
17
2124
Televere Podiatry Digital Imaging System
2
Cleared 510(K)
K
17
2951
Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)
2
Cleared 510(K)
K
17
2784
DX-D Imaging Package
2
Cleared 510(K)
K
17
2435
Galaxy R Digital Radiography Upgrade
2
Cleared 510(K)
K
17
2793
SKR 3000
2
Cleared 510(K)
K
17
1169
Aquarius 8600 1417TG and Aquarius 8600 1717TG
2
Cleared 510(K)
K
17
2681
Edge Air Digital Flat Panel X-ray Detector
2
Cleared 510(K)
K
17
2682
Edge Digital Flat Panel X-ray Detector
2
Cleared 510(K)
K
17
1175
Aquarius 8600 1417WC
2
Cleared 510(K)
K
17
2581
CareView 1800Cw X-ray Flat Panel Detectors
2
Cleared 510(K)
K
17
1716
SKR 3000
2
Cleared 510(K)
K
17
1461
SkyPlate Detector for Philips Radiography/Fluoroscopy Systems
2
Cleared 510(K)
K
17
0480
Models 3543A, 4343A, 2929A and A843B
2
Cleared 510(K)
K
16
3624
Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)
2
Cleared 510(K)
K
17
1485
BSD4343R Digital Flat Panel X-ray Detector
2
Cleared 510(K)
K
17
1417
1417WGC_127um and 1417WGC_140um
2
Cleared 510(K)
K
17
1418
1417WCC_127um and1417WCC_140um
2
Cleared 510(K)
K
17
1419
1717SGC_127um and 1717SGC_140um
2
Cleared 510(K)
K
17
1420
1717SCC_127um and 1717SCC_140um
2
Cleared 510(K)
K
17
1138
Nexus DR Digital X-ray Imaging System
2
Cleared 510(K)
K
17
1137
EVS 2430W, EVS 2430GW
2
Cleared 510(K)
K
17
1085
GMR40
2
Cleared 510(K)
K
17
0975
Televere Digital Imaging System
2
Cleared 510(K)
K
16
3157
SmartGrid
2
Cleared 510(K)
K
17
0332
DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS
2
Cleared 510(K)
K
17
0202
Aquarius 8600
2
Cleared 510(K)
K
17
0113
pixium 4343RCE
2
Cleared 510(K)
K
16
3703
VIVIX-S 1417N
2
Cleared 510(K)
K
16
2909
CSX-30 Flat Panel Detector
2
Cleared 510(K)
K
16
2555
EVS 4343, EVS 4343G
2
Cleared 510(K)
K
16
2344
INNOLUX RIC
2
Cleared 510(K)
K
16
1730
Wireless Digital Flat Panel Detector
2
Cleared 510(K)
K
16
2552
EVS 3643, EVS 3643G
2
Cleared 510(K)
K
16
3019
CareView 750Cw/750C X-ray Flat Panel Detectors
2
Cleared 510(K)
K
16
0143
ClearVision ExamVue Flat Panel Detector
2
Cleared 510(K)
K
16
2487
BSD3543 Digital Flat Panel X-ray Detector
2
Cleared 510(K)
K
16
2519
1717WCC / 1717WGC
2
Cleared 510(K)
K
16
2518
1012WCC, 1012WGC
2
Cleared 510(K)
K
16
2504
SKR 3000
2
Cleared 510(K)
K
16
1368
DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)
2
Cleared 510(K)
K
16
1966
PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector
2
Cleared 510(K)
K
16
1459
Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)
2
Cleared 510(K)
K
16
2178
CareView 1500P X-ray Flat Panel Detectors
2
Cleared 510(K)
K
16
1942
PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector
2
Cleared 510(K)
K
15
3312
SCATTER CORRECTION FOR CXDI SERIES
2
Cleared 510(K)
K
16
0204
BSD4343 Digital Flat Panel X-ray Detector
2
Cleared 510(K)
K
16
0810
ViZion DR + Wireless
2
Cleared 510(K)
K
15
3464
FDR D-EVO flat Panel Detector System
2
Cleared 510(K)
K
15
3710
Tuxedo Digital Dental Sensor
2
Cleared 510(K)
K
15
2894
VIVIX-S 1717N
2
Cleared 510(K)
K
15
2855
VIVIX-S 1012N
2
Cleared 510(K)
K
15
3492
CareView 1800L
2
Cleared 510(K)
K
15
3318
Philips Eleva Workspot with SkyFlow
2
Cleared 510(K)
K
15
3401
GR40CW
2
Cleared 510(K)
K
15
2639
DR 600
2
Cleared 510(K)
K
15
3142
Carestream DRX-1 System with DRX Plus 4343 Detectors
2
Cleared 510(K)
K
15
3058
CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors
2
Cleared 510(K)
K
15
2151
ATAL 9
2
Cleared 510(K)
K
15
2138
FDR D-EVO GL Flat Panel Detector System
2
Cleared 510(K)
K
15
1942
EVS 3643
2
Cleared 510(K)
K
15
2094
GR40CW
2
Cleared 510(K)
K
15
2279
ViZion DR + Wireless
2
Cleared 510(K)
K
14
1488
CAREVIEW 1800R
2
Cleared 510(K)
K
15
0929
CareView 1500Cw X-ray Flat Panel Detectors
2
Cleared 510(K)
K
15
1014
Aura DR 43C-AG flat panel detector
2
Cleared 510(K)
K
15
1465
AeroDR SYSTEM 2
2
Cleared 510(K)
K
15
0766
Carestream DRX-1 System
2
Cleared 510(K)
K
15
1221
Kubtec DIGIVIEW 395
2
Cleared 510(K)
K
15
0150
1717SGN / 1717SCN Digital Flat Panel X-ray Detector
2
Cleared 510(K)
K
14
3232
Universal Digital Interface 2W, UDI 2W
2
Cleared 510(K)
K
14
3000
RIS500
2
Cleared 510(K)
K
14
2475
EVS 4343
2
Cleared 510(K)
K
14
2718
Radlink GPS
2
Cleared 510(K)
K
14
2698
PerkinElmer, XRpad 4343 F MED Flat Panel Detector
2
Cleared 510(K)
K
14
0251
UNIVERSAL DIGITAL INTERFACE 2, UDI 2
2
Cleared 510(K)
K
14
2003
FDR D-EVO II FLAT PANEL DETECTOR SYSTEM
2
Cleared 510(K)
K
14
2184
DX-D IMAGING PACKAGE
2
Cleared 510(K)
K
14
1765
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
2
Cleared 510(K)
K
14
1743
FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT
2
Cleared 510(K)
K
14
1271
AERODR SYSTEM 2
2
Cleared 510(K)
K
14
1602
DX-D IMAGING PACKAGE
2
Cleared 510(K)
K
14
1440
DICOMPACS DX-R WITH FLAT PANEL
2
Cleared 510(K)
K
14
1435
OPAL CHIRO, 20/20 P-DR
2
Cleared 510(K)
K
14
0551
PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR
2
Cleared 510(K)
K
14
1736
PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST
2
Cleared 510(K)
K
14
0825
DELWORKS DR SYSTEM
2
Cleared 510(K)
K
14
1566
SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC
2
Cleared 510(K)
K
14
1563
SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC
2
Cleared 510(K)
K
13
3693
DIGITAL RADIOGRAPHY CXDI-401C WIRELESS
2
Cleared 510(K)
K
14
1192
DR 400
2
Cleared 510(K)
K
14
0235
XGEO GR40CW
2
Cleared 510(K)
K
14
0056
DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A
2
Cleared 510(K)
K
14
0060
DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A
2
Cleared 510(K)
K
14
0771
PHILIPS ELEVA WORKSPOT
2
Cleared 510(K)
K
13
3524
PVMED DDR 2430T
2
Cleared 510(K)
K
14
0646
DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G
2
Cleared 510(K)
K
13
3139
VIZION ULTRA
2
Cleared 510(K)
K
13
3782
NOVA FA DR SYSTEM
2
Cleared 510(K)
K
13
3442
BONE SUPPRESSION SOFTWARE
2
Cleared 510(K)
K
13
3409
DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA
2
Cleared 510(K)
K
13
2842
FLAATZ 600 SERIES (FLAATZ 600/601)
2
Cleared 510(K)
K
13
2921
GALAXY PLUS
2
Cleared 510(K)
K
13
3120
COMPUTED RADIOGRAPHY SCANNER
2
Cleared 510(K)
K
13
3106
COMPUTED RADIOGRAPHY SCANNER
2
Cleared 510(K)
K
13
2509
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
2
Cleared 510(K)
K
13
1211
DICOMPACS DX-R WITH FLAT PANEL
2
Cleared 510(K)
K
13
1483
PHILIPS PIXIUM 4343RC
2
Cleared 510(K)
K
13
1114
DIGITAL FLAT PANEL X-RAY DETECTOR
2
Cleared 510(K)
K
13
1408
CR 12-X DIGITIZER
2
Cleared 510(K)
K
13
0936
AERODR SYSTEM WITH P-31
2
Cleared 510(K)
K
13
1106
DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS,
2
Cleared 510(K)
K
13
0935
DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA
2
Cleared 510(K)
K
13
1314
DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)
2
Cleared 510(K)
K
13
0567
DR LONG LENGTH IMAGING SOFTWARE
2
Cleared 510(K)
K
13
0464
CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR
2
Cleared 510(K)
K
13
0377
KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
2
Cleared 510(K)
K
13
0883
SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T
2
Cleared 510(K)
K
12
3345
DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA
2
Cleared 510(K)
K
12
2736
DX-D IMAGING PACKAGE
2
Cleared 510(K)
K
12
3740
EOS
2
Cleared 510(K)
K
12
2865
VIVIX-S WIRELESS
2
Cleared 510(K)
K
12
2928
DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA
2
Cleared 510(K)
K
12
3644
VIZION + DR
2
Cleared 510(K)
K
12
2866
VIVIX-S WITH VXVUE
2
Cleared 510(K)
K
12
2919
DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA
2
Cleared 510(K)
K
12
3499
AEROPILOT
2
Cleared 510(K)
K
12
3005
DDRVERSA MOTION
2
Cleared 510(K)
K
12
2495
PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR
2
Cleared 510(K)
K
12
2173
DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC
2
Cleared 510(K)
K
12
2842
RADREX-I, SW V4.00 MODEL DRAD-3000E
2
Cleared 510(K)
K
12
0629
FDR GO FLEX
2
Cleared 510(K)
K
12
2182
DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC
2
Cleared 510(K)
K
12
1095
DX-D IMAGING PACKAGE
2
Cleared 510(K)
K
12
1948
CR 10-X DIGITIZER
2
Cleared 510(K)
K
12
1838
LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM
2
Cleared 510(K)
K
11
3449
FUSION FLAT PANEL
2
Cleared 510(K)
K
11
2527
UNIVERSAL DIGITAL INTERFACE (UDI) 1717
2
Cleared 510(K)
K
12
1132
EZSENSOR P DIGITAL INTRAORAL SENSOR
2
Cleared 510(K)
K
12
0020
VIVIX-S
2
Cleared 510(K)
K
11
3812
ATAL-8
2
Cleared 510(K)
K
11
1824
FLAT PANEL DETECTOR
2
Cleared 510(K)
K
10
2327
CLEARVISION DR 7000F
2
Cleared 510(K)
K
12
0477
AEROSYNC FOR AERODR SYSTEM
2
Cleared 510(K)
K
12
0721
EOS
2
Cleared 510(K)
K
12
0380
SATURN 8000
2
Cleared 510(K)
K
12
0131
REGIUS SIGMA2
2
Cleared 510(K)
K
11
1305
UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W
2
Cleared 510(K)
K
11
3630
DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA
2
Cleared 510(K)
K
11
2751
SDX-4343CS
2
Cleared 510(K)
K
11
3052
INFINIX-CCI
2
Cleared 510(K)
K
11
2132
KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
2
Cleared 510(K)
K
11
2558
DIGITAL FLAT PANEL X-RAY DETECTOR
2
Cleared 510(K)
K
11
2661
VIZION DR
2
Cleared 510(K)
K
10
3348
DIGIVIEW 250
2
Cleared 510(K)
K
11
1583
FLAATZ 560
2
Cleared 510(K)
K
11
1865
WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE
2
Cleared 510(K)
K
11
2309
DIGITAL RADIOGRAPHY
2
Cleared 510(K)
K
11
1682
DIGITAL RADIOGRAPHY
2
Cleared 510(K)
K
11
1548
WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE
2
Cleared 510(K)
K
11
0801
WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
2
Cleared 510(K)
K
11
1312
SANTEVIEW
2
Cleared 510(K)
K
10
3703
REGUIS SIGMA
2
Cleared 510(K)
K
10
2479
ALARA T210 COMPUTED RADIOGRAPHY SYSTEM
2
Cleared 510(K)
K
11
1098
INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN
2
Cleared 510(K)
K
10
2619
COMPUTED RADDIOGRAPHY SCANNER
2
Cleared 510(K)
K
10
3599
UNIVERSAL DIGITAL INTERFACE (UDI) 1717
2
Cleared 510(K)
K
11
0210
SATURN 8000-GS
2
Cleared 510(K)
K
10
3596
WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR
2
Cleared 510(K)
K
10
3591
DIGITAL RADIOGRAPHY
2
Cleared 510(K)
K
10
2474
FLAATZ 750E
2
Cleared 510(K)
K
10
2321
DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP
2
Cleared 510(K)
K
10
0703
STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS
2
Cleared 510(K)
K
10
2587
LLX240AB01
2
Cleared 510(K)
K
10
1590
DIGITAL FLAT PANEL X-RAY DETECTOR
2
Cleared 510(K)
K
10
2615
WIRELESS DR IMAGING OPTION-WDR1
2
Cleared 510(K)
K
10
2012
DIGITAL RADIOGRAPHY
2
Cleared 510(K)
K
09
1090
DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717
2
Cleared 510(K)
K
10
1289
SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB
2
Cleared 510(K)
K
10
0762
FLAT PANEL DETECTOR, MODEL FDR D-EVO
2
Cleared 510(K)
K
10
0001
MOBIVISION
2
Cleared 510(K)
K
09
3790
SIMONDR DRP
2
Cleared 510(K)
K
09
3427
FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR
2
Cleared 510(K)
K
09
2669
DX-D IMAGING PACKAGE
2
Cleared 510(K)
K
09
2717
DIRECT DIGITIZER, REGIUS MODEL 210
2
Cleared 510(K)
K
09
0742
DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A
2
Cleared 510(K)
K
09
2238
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS
2
Cleared 510(K)
K
08
2450
IDR
2
Cleared 510(K)
K
09
1545
DIGITAL RADIOGRAPHY CXDI-60C
2
Cleared 510(K)
K
09
1436
DIGITAL RADIOGRAPHY, MODEL CXDI-55C
2
Cleared 510(K)
K
09
1435
DIGITAL RADIOGRAPHY MODEL CXDI-55G
2
Cleared 510(K)
K
09
0672
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS
2
Cleared 510(K)
K
09
0062
WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
2
Cleared 510(K)
K
09
0318
CARESTREAM DRX-1 SYSTEM
2
Cleared 510(K)
K
09
0625
WIRELESS PORTABLE DETECTOR FD-W17
2
Cleared 510(K)
K
09
0623
DIGITAL RADIOGRAPHY CXDI-40G COMPACT
2
Cleared 510(K)
K
08
3224
CPI RAD VISION, MODEL VZW2944XX-YY
2
Cleared 510(K)
K
08
3645
RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS
2
Cleared 510(K)
K
08
2347
DIGITAL RADIOGRAPHY, FLEXDR C30
2
Cleared 510(K)
K
08
2494
DRAD3000E/RADREX-I
2
Cleared 510(K)
K
08
1963
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS
2
Cleared 510(K)
K
08
1648
DIGITAL RADIOGRAPHY CXDI-60G
2
Cleared 510(K)
K
08
1624
INFX-8000F (INFINIX CSI AND INFINIX DPI)
2
Cleared 510(K)
K
08
0589
SATURN 9000-810
2
Cleared 510(K)
K
07
3670
KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260
2
Cleared 510(K)
K
08
0064
FLAATZ 750
2
Cleared 510(K)
K
07
3165
DRAD-3000E, RADREX-I
2
Cleared 510(K)
K
07
2984
SATURN 9000-550
2
Cleared 510(K)
K
07
3056
DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9
2
Cleared 510(K)
K
07
2983
SATURN 9000-750
2
Cleared 510(K)
K
07
1682
CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER)
2
Cleared 510(K)
K
06
3710
SATURN 9000
2
Cleared 510(K)
K
07
1193
VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS
2
Cleared 510(K)
K
07
1181
DIRECT DIGITIZER, REGIUS MODEL 110
2
Cleared 510(K)
K
07
0829
SYNEPIX 4600 DETECTOR
2
Cleared 510(K)
K
07
1162
AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS
2
Cleared 510(K)
K
07
0563
VIDAR VISION 2000
2
Cleared 510(K)
K
07
0528
PHILIPS ESSENTA DR
2
Cleared 510(K)
K
07
0079
X3C DIGITAL RADIOGRAPHIC DETECTOR
2
Cleared 510(K)
K
06
3421
DX-SI
2
Cleared 510(K)
K
06
3283
DEFINIUM 5000 X-RAY SYSTEM
2
Cleared 510(K)
K
06
3039
XPLORER 2200 DIGITAL RADIOGRAPHIC SYSTEM
2
Cleared 510(K)
K
06
2376
DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI
2
Cleared 510(K)
K
06
2742
CR 85-X
2
Cleared 510(K)
K
06
2586
XPLORER 1600 PLUS
2
Cleared 510(K)
K
06
2390
CRYSTALVIEW R200
2
Cleared 510(K)
K
06
2223
AGFA MODEL CR30-X
2
Cleared 510(K)
K
06
2221
CXDI-40EC
2
Cleared 510(K)
K
06
1538
ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200
2
Cleared 510(K)
K
05
2661
QUIX DIGITAL RADIOGRAPHIC UPGRADE
2
Cleared 510(K)
K
06
1054
AXIOM ARISTOS FX PLUS
2
Cleared 510(K)
K
06
0137
KODAK ECLIPSE IMAGE PROCESSING SOFTWARE
2
Cleared 510(K)
K
06
0433
DIGITAL RADIOGRAPHY CXDI-50C
2
Cleared 510(K)
K
05
3634
COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION
2
Cleared 510(K)
K
05
3029
NDR+/DIVA-D
2
Cleared 510(K)
K
05
2938
CR-PRO
2
Cleared 510(K)
K
05
2095
MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190
2
Cleared 510(K)
K
05
1998
REGIUS MODEL 170 DIRECT DIGITIZER
2
Cleared 510(K)
K
05
1494
MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001
2
Cleared 510(K)
K
05
2136
GR17 DIGITAL DETECTOR
2
Cleared 510(K)
K
05
1418
DIRECT DIGITIZER REGIUS MODEL 370
2
Cleared 510(K)
K
04
2791
INSTANT-X, MODELS 1713 & 128
2
Cleared 510(K)
K
05
1483
KODAK DIRECTVIEW DR SYSTEM DETECTOR
2
Cleared 510(K)
K
05
0925
DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE
2
Cleared 510(K)
K
05
0718
DDRCOMBI TRAUMA
2
Cleared 510(K)
K
05
0987
DIGITAL RADIOGRAPHY MODEL CXDI-40EG
2
Cleared 510(K)
K
05
0810
AGFA CR50.0
2
Cleared 510(K)
K
04
2602
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING
2
Cleared 510(K)
K
04
2386
DIRECT DIGITIZER, REGIUS MODEL 190
2
Cleared 510(K)
K
04
2821
DIGITAL DETECTOR, MODEL GR17
2
Cleared 510(K)
K
04
2397
SCANX 14
2
Cleared 510(K)
K
04
2041
XPLORER 1600
2
Cleared 510(K)
K
04
2023
FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER
2
Cleared 510(K)
K
04
1701
AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM
2
Cleared 510(K)
K
03
3561
FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER
2
Cleared 510(K)
K
03
2210
ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM
2
Cleared 510(K)
K
03
1198
SCANX 10
2
Cleared 510(K)
K
03
1633
CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C
2
Cleared 510(K)
K
03
1447
CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G
2
Cleared 510(K)
K
02
4147
PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM
2
Cleared 510(K)
K
02
3750
CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G
2
Cleared 510(K)
K
02
3586
DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS
2
Cleared 510(K)
K
02
3061
KONICA DIRECT DIGITIZER REGIUS, MODEL 170
2
Cleared 510(K)
K
02
3124
CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT
2
Cleared 510(K)
K
02
1829
MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM
2
Cleared 510(K)
K
01
3897
SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW
2
Cleared 510(K)
K
02
0635
KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622; KODAK DIRECTVIEW CR 900 SYSTEM, CATALOG# 1170976
2
Cleared 510(K)
K
01
3054
KONICA DIRECT DIGITIZER REGIUS MODEL 350
2
Cleared 510(K)
K
01
3218
FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II
2
Cleared 510(K)
K
01
2750
ADC PEDIATRIC
2
Cleared 510(K)
K
00
3238
SOLID STATE X-RAY IMAGING DEVICES
2
Cleared 510(K)
K
01
3138
ADC COMPACT PLUS
2
Cleared 510(K)
K
00
3438
SMART RAD
2
Cleared 510(K)
K
00
1499
PHORMAX EAGLE SCANNER SYSTEM
2
Cleared 510(K)
K
00
3256
PCCR DIGITAL IMAGING DEVICE
2
Cleared 510(K)
K
99
2955
XPLORER 1000
2
Cleared 510(K)
K
99
3861
FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER
2
Cleared 510(K)
K
99
2794
STINGRAY DR, MODEL 1
2
Cleared 510(K)
K
99
2547
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22
2
Cleared 510(K)
K
99
0359
KONICA DIRECT DIGITIZER, MODEL DD-341
2
Cleared 510(K)
K
98
3732
THORAX FD AND MULTIX FD
2
Cleared 510(K)
K
98
2661
CDR - PAN MODEL 4700
2
Cleared 510(K)
K
98
2795
PHILIPS BUCKY VISION
2
Cleared 510(K)
K
98
1556
CANON X-RAY DIGITAL CAMERA CXDI-11
2
Cleared 510(K)
K
97
3206
STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY
2
Cleared 510(K)
MUA
Bone Sonometer
2
Product Code
MUE
Full Field Digital, System, X-Ray, Mammographic
2
Product Code
MUI
Media, Coupling, Ultrasound
2
Product Code
MWP
Cabinet, X-Ray System
2
Product Code
MYN
Analyzer, Medical Image
2
Product Code
NCS
System, Imaging, Holography, Acoustic
2
Product Code
NWE
Colon Computed Tomography System, Computer Aided Detection
2
Product Code
OAS
X-Ray, Tomography, Computed, Dental
2
Product Code
OEB
Lung Computed Tomography System, Computer-Aided Detection
2
Product Code
OII
Arthrogram Tray
2
Product Code
OIJ
Biopsy Needle Guide Kit
2
Product Code
OIK
Radiology Dental Tray
2
Product Code
OIL
Discography Kit
2
Product Code
OIM
Mri Disposable Kit
2
Product Code
OIO
Radiographic Contrast Tray
2
Product Code
OIP
Radiology-Diagnostic Kit
2
Product Code
OMJ
Chest X-Ray Computer Aided Detection
2
Product Code
OQQ
Diagnostic Ultrasonic Transducer, Robotic
2
Product Code
OUO
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
2
Product Code
OWB
Interventional Fluoroscopic X-Ray System
2
Product Code
OXO
Image-Intensified Fluoroscopic X-Ray System, Mobile
2
Product Code
PGY
Display, Diagnostic Radiology
2
Product Code
POK
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
2
Product Code
QAS
Radiological Computer-Assisted Triage And Notification Software
2
Product Code
QFM
Radiological Computer-Assisted Prioritization Software For Lesions
2
Product Code
QHA
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
2
Product Code
QHX
Fluoroscopic X-Ray Image Intensifier
1
Product Code
QHY
Solid State Fluoroscopic X-Ray Imager
2
Product Code
QIH
Automated Radiological Image Processing Software
2
Product Code
QKB
Radiological Image Processing Software For Radiation Therapy
2
Product Code
RCC
C-Arm Fluoroscopic X-Ray System
2
Product Code
QTZ
Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
2
Product Code
QXL
Cabinet, Emission Computed Tomography System
2
Product Code
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
RA
/
subpart-b—diagnostic-devices
/
MQB
/
K171716
View Source
SKR 3000
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171716
510(k) Type
Traditional
Applicant
Konica Minolta, Inc.
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
8/25/2017
Days to Decision
77 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
Miscellaneous
Subpart B—Diagnostic Devices
EAG
Cephalometer
EAH
Cone, Radiographic, Lead-Lined
EAP
Unit, X-Ray, Intraoral
EHB
Collimator, X-Ray
EHD
Unit, X-Ray, Extraoral With Timer
MUH
System, X-Ray, Extraoral Source, Digital
EAM
Screen, Intensifying, Radiographic
EGT
Controller, Temperature, Radiographic
EGW
Dryer, Film, Radiographic
EGY
Processor, Radiographic-Film, Automatic, Dental
HBK
Chair, Pneumoencephalographic
ITX
Transducer, Ultrasonic, Diagnostic
ITY
Assembly, Tube Housing, X-Ray, Diagnostic
IWN
Cassette, Measurement, Ardran-Crooks
IWY
Holder, Head, Radiographic
IWZ
Film, Radiographic
IXA
Cassette, Radiographic Film
IXC
Illuminator, Radiographic-Film
IXD
Source, Calibration, Sealed, Nuclear
IXF
Test-Pattern, Radiographic
IXG
Phantom, Anthropomorphic, Radiographic
IXH
Camera, Focal Spot, Radiographic
IXJ
Grid, Radiographic
IXK
System, Imaging, X-Ray, Electrostatic
IXL
Device, Spot-Film
IXO
Synchronizer, Ecg / Respirator, Radiographic
IXQ
Table, Radiographic, Stationary Top
IXR
Table, Radiographic, Tilting
IXW
Processor, Radiographic-Film, Automatic
IXX
Processor, Cine Film
IXY
Holder, Radiographic Cassette, Wall-Mounted
IYB
Tube Mount, X-Ray, Diagnostic
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
IYO
System, Imaging, Pulsed Echo, Ultrasonic
IYP
Phantom, Anthropomorphic, Nuclear
IYQ
Phantom, Flood Source, Nuclear
IYT
System, Rebreathing, Radionuclide
IYW
Scanner, Rectilinear, Nuclear
IYX
Camera, Scintillation (Gamma)
IYY
Synchronizer, Electrocardiograph, Nuclear
IYZ
Bed, Scanning, Nuclear
IZC
Camera, Positron
IZD
Probe, Uptake, Nuclear
IZF
System, X-Ray, Tomographic
IZG
System, X-Ray, Photofluorographic
IZH
System, X-Ray, Mammographic
IZI
System, X-Ray, Angiographic
IZJ
Camera, X-Ray, Fluorographic, Cine Or Spot
IZL
System, X-Ray, Mobile
IZO
Generator, High-Voltage, X-Ray, Diagnostic
IZP
Programmer, Changer, Film/Cassette, Radiographic
IZS
Aperture, Radiographic
IZT
Cone, Radiographic
IZW
Collimator, Automatic, Radiographic
IZX
Collimator, Manual, Radiographic
IZZ
Table, Radiographic, Non-Tilting, Powered
JAA
System, X-Ray, Fluoroscopic, Image-Intensified
JAB
System, X-Ray, Fluoroscopic, Non-Image-Intensified
JAC
System, X-Ray, Film Marking, Radiographic
JAF
Monitor, Ultrasonic, Nonfetal
JAG
Illuminator, Radiographic-Film, Explosion-Proof
JAK
System, X-Ray, Tomography, Computed
JAM
Scanner, Whole Body, Nuclear
JAN
Counter, Whole Body, Nuclear
JAO
Scanner, Fluorescent
JAR
Phantom, Test-Pattern, Radionuclide
JWM
System, Tomographic, Nuclear
KGI
Densitometer, Bone
KPR
System, X-Ray, Stationary
KPS
System, Tomography, Computed, Emission
KPT
Calibrator, Dose, Radionuclide
KPW
Device, Beam Limiting, X-Ray, Diagnostic
KPX
Changer, Radiographic Film/Cassette
KXH
Cradle, Patient, Radiologic
KXJ
Table, Radiologic
LEK
Transilluminator (Diaphanoscope)
LHO
Instrument, Quality-Assurance, Radiologic
LLZ
System, Image Processing, Radiological
LMA
Digitizer, Image, Radiological
LMB
Device, Digital Image Storage, Radiological
LMC
Camera, Multi Format, Radiological
LMD
System, Digital Image Communications, Radiological
LNH
System, Nuclear Magnetic Resonance Imaging
LNI
System, Nuclear Magnetic Resonance Spectroscopic
LQA
Media, Reusable Image
MOS
Coil, Magnetic Resonance, Specialty
MQB
Solid State X-Ray Imager (Flat Panel/Digital Imager)
K
24
0371
0909FCC, 0909FCC-HS
K
23
2082
EXPD 4343S
K
23
2753
EXPD 4343D; EXPD 3643D
K
23
0918
MasterX 800 Series
K
23
2058
YosemiteView 4343W/YosemiteView 3643W
K
23
1959
EXPD 4357; EXPD 4357P
K
23
1709
AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4
K
23
1467
1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF
K
22
3930
A1417MCW/A1717MCW/F1417MCW
K
23
0175
Digital Radiography CXDI-CS01
K
23
0059
Digital Flat Panel Detector
K
22
3546
14HQ721G-B
K
22
3687
X-ray Flat Panel Detectors (EverestView 4343X)
K
22
3009
Wireless/Wired X-Ray Flat Panel Detectors
K
22
3124
EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
K
22
3267
SKR 3000
K
22
2886
Mercu 1717V
K
22
2855
Digital Radiography CXDI-Pro, Digital Radiography D1
K
22
2687
Digital Radiography CXDI-Elite, Digital Radiography E1
K
22
2661
Digital Radiography CXDI-CS01
K
22
0239
Solid State X-ray Imager(Model: FXRD-4386WB)
K
22
1549
X-ray Flat Panel Detectors (CareView 1800 RF)
K
22
1461
10HQ701G-B
K
22
1394
14HQ701G-B
K
22
1512
Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)
K
22
1876
Digital Radiography CXDI-Pro, Digital Radiography D1
K
22
1434
17HQ701G-B
K
22
1714
Flat Panel Detector
K
22
1345
Wireless Digital Flat Panel Detector
K
22
1620
Digital Radiography CXDI-Elite, Digital Radiography E1
K
22
1144
PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG
K
22
0559
17HQ901G-B
K
22
0536
Digital flat panel detector
K
22
0510
Yushan X-Ray Flat Panel Detector with DROC
K
22
0668
Wireless Digital Flat Panel Detector
K
21
3646
Focus HD 35 Detector
K
21
3529
Focus HD 43 Detector
K
21
4044
14HQ901G-B
K
22
0098
Digital Radiography CXDI-Pro, Digital Radiography D1
K
21
3908
SKR 3000
K
21
3780
DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1
K
21
4030
Universal DR 1748
K
21
3307
Eclipse II with Smart Noise Cancellation
K
21
3469
VALORY
K
21
3497
ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)
K
21
2753
0909FCB, 1212FCA
K
21
2269
Intelligent NR
K
21
2553
DIGITAL RADIOGRAPHY CXDI-Pro, D1
K
21
2051
RFA-1717DIG, RFA-1717DIC
K
21
0619
SKR 3000
K
21
2105
6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF
K
21
1790
DX-D Imaging Package with XD Detectors
K
21
1542
PRIMO S
K
21
1108
Prudent 1717, Prudent 1417, Prudent 1212
K
21
0919
AcuityDRe
K
21
0985
1717FCC
K
21
0988
Yushan X-Ray Flat Panel Detector with DROC
K
20
2441
Eclipse II with Smart Noise Cancellation
K
20
3703
I-Q View
K
20
3188
ADD
K
21
0316
Mars 1417X Wireless Digital Flat Panel Detector
K
21
0314
Mars1717X Wireless Digital Flat Panel Detector
K
20
2995
X-ray Flat Panel Detectors/CareView 3600RF
K
20
3849
General Radiography CXDI-CS01
K
20
3159
Lux 35 Detector
K
20
2722
1212FCA
K
20
1528
Yushan X-Ray Flat Panel Detector with DROC
K
20
2564
DigitalDiagnost C90
K
20
1591
Flat Panel Detector
K
20
1932
X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)
K
20
1796
1717SCV, 1717SGV
K
20
1503
Edge Air(1417) Digital Flat Panel X-ray Detector
K
20
1247
Intraoral Sensor
K
20
1043
Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)
K
20
1058
Accuvue+
K
20
1004
Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W
K
20
0787
BSD3543W
K
20
0668
DR-ID 1200SDK System
K
20
0622
Focus 43C detector, TRIMAX 43C detector
K
20
0418
VIVIX-S VW
K
19
2894
Vita Flex CR System with LLI
K
19
3644
E-COM DR-2000 DR
K
20
0018
HAD1717MC
K
19
3238
Nexus DR Digital X-Ray Imaging System (with vSharp)
K
19
3173
CareView 1800Le
K
19
3031
EXPD 4343P, EXPD 3643P
K
19
3017
EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP
K
19
2932
FDR D-EVO III flat panel detector system
K
19
2632
DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless
K
19
2440
FDR SE Lite
K
19
2512
Focus 35C Detector, Trimax 35C Detector
K
19
2400
EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG
K
19
1939
Yushan X-Ray Flat Panel Detector
K
19
1645
SKR 4000
K
19
0611
VIVIX-S 1751S
K
19
0691
Pixx2430 Digital Diagnostic X-Ray Receptor Panel
K
19
0368
Enhanced Feature Software Pack CXDI Series
K
19
0311
BIOK7600 Flat Panel Detector
K
19
0300
BIOK7600W Wireless Flat Panel Detector
K
19
0146
Nexus DR Digital X-ray Imaging System
K
18
3245
Carestream DRX-1 System with DRX Plus 2530 Detectors
K
18
3474
Carestream DRX-1 System with DRX Core Detectors
K
18
2973
DigitalDiagnost C90
K
18
3713
Wireless Digital Flat Detector
K
18
3422
Wireless Digital Flat Panel Detector
K
18
2688
SKR 3000
K
18
3286
17HK701G-W
K
18
3212
Nexus DR Digital X-ray Imaging System with stitching
K
18
2348
14HK701G-W
K
18
2551
Wireless Digital Flat Panel Detector
K
18
2550
Wireless Digital Flat Panel Detector
K
18
2533
PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels
K
18
1631
GR40CW
K
18
1565
Aquarius 8600 Digital Radiography Sensor
K
18
1526
XRpad2 4343 HWC-M Flat Panel Detector
K
18
0809
Eclipse II
K
18
0989
PEDRA-17F Digital Flat Panel X-ray Detector
K
18
0332
17HK700G-W
K
18
0976
PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels
K
18
1003
VIVIX-S 1717V
K
18
0667
SmartGrid
K
17
1270
DIGITAL RADIOGRAPHY CXDI-410C WIRELESS
K
17
3273
Aquarius 8600 1417WCI; Aquarius 8600 1717WCI
K
17
2124
Televere Podiatry Digital Imaging System
K
17
2951
Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)
K
17
2784
DX-D Imaging Package
K
17
2435
Galaxy R Digital Radiography Upgrade
K
17
2793
SKR 3000
K
17
1169
Aquarius 8600 1417TG and Aquarius 8600 1717TG
K
17
2681
Edge Air Digital Flat Panel X-ray Detector
K
17
2682
Edge Digital Flat Panel X-ray Detector
K
17
1175
Aquarius 8600 1417WC
K
17
2581
CareView 1800Cw X-ray Flat Panel Detectors
K
17
1716
SKR 3000
K
17
1461
SkyPlate Detector for Philips Radiography/Fluoroscopy Systems
K
17
0480
Models 3543A, 4343A, 2929A and A843B
K
16
3624
Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)
K
17
1485
BSD4343R Digital Flat Panel X-ray Detector
K
17
1417
1417WGC_127um and 1417WGC_140um
K
17
1418
1417WCC_127um and1417WCC_140um
K
17
1419
1717SGC_127um and 1717SGC_140um
K
17
1420
1717SCC_127um and 1717SCC_140um
K
17
1138
Nexus DR Digital X-ray Imaging System
K
17
1137
EVS 2430W, EVS 2430GW
K
17
1085
GMR40
K
17
0975
Televere Digital Imaging System
K
16
3157
SmartGrid
K
17
0332
DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS
K
17
0202
Aquarius 8600
K
17
0113
pixium 4343RCE
K
16
3703
VIVIX-S 1417N
K
16
2909
CSX-30 Flat Panel Detector
K
16
2555
EVS 4343, EVS 4343G
K
16
2344
INNOLUX RIC
K
16
1730
Wireless Digital Flat Panel Detector
K
16
2552
EVS 3643, EVS 3643G
K
16
3019
CareView 750Cw/750C X-ray Flat Panel Detectors
K
16
0143
ClearVision ExamVue Flat Panel Detector
K
16
2487
BSD3543 Digital Flat Panel X-ray Detector
K
16
2519
1717WCC / 1717WGC
K
16
2518
1012WCC, 1012WGC
K
16
2504
SKR 3000
K
16
1368
DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)
K
16
1966
PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector
K
16
1459
Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)
K
16
2178
CareView 1500P X-ray Flat Panel Detectors
K
16
1942
PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector
K
15
3312
SCATTER CORRECTION FOR CXDI SERIES
K
16
0204
BSD4343 Digital Flat Panel X-ray Detector
K
16
0810
ViZion DR + Wireless
K
15
3464
FDR D-EVO flat Panel Detector System
K
15
3710
Tuxedo Digital Dental Sensor
K
15
2894
VIVIX-S 1717N
K
15
2855
VIVIX-S 1012N
K
15
3492
CareView 1800L
K
15
3318
Philips Eleva Workspot with SkyFlow
K
15
3401
GR40CW
K
15
2639
DR 600
K
15
3142
Carestream DRX-1 System with DRX Plus 4343 Detectors
K
15
3058
CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors
K
15
2151
ATAL 9
K
15
2138
FDR D-EVO GL Flat Panel Detector System
K
15
1942
EVS 3643
K
15
2094
GR40CW
K
15
2279
ViZion DR + Wireless
K
14
1488
CAREVIEW 1800R
K
15
0929
CareView 1500Cw X-ray Flat Panel Detectors
K
15
1014
Aura DR 43C-AG flat panel detector
K
15
1465
AeroDR SYSTEM 2
K
15
0766
Carestream DRX-1 System
K
15
1221
Kubtec DIGIVIEW 395
K
15
0150
1717SGN / 1717SCN Digital Flat Panel X-ray Detector
K
14
3232
Universal Digital Interface 2W, UDI 2W
K
14
3000
RIS500
K
14
2475
EVS 4343
K
14
2718
Radlink GPS
K
14
2698
PerkinElmer, XRpad 4343 F MED Flat Panel Detector
K
14
0251
UNIVERSAL DIGITAL INTERFACE 2, UDI 2
K
14
2003
FDR D-EVO II FLAT PANEL DETECTOR SYSTEM
K
14
2184
DX-D IMAGING PACKAGE
K
14
1765
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
K
14
1743
FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT
K
14
1271
AERODR SYSTEM 2
K
14
1602
DX-D IMAGING PACKAGE
K
14
1440
DICOMPACS DX-R WITH FLAT PANEL
K
14
1435
OPAL CHIRO, 20/20 P-DR
K
14
0551
PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR
K
14
1736
PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST
K
14
0825
DELWORKS DR SYSTEM
K
14
1566
SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC
K
14
1563
SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC
K
13
3693
DIGITAL RADIOGRAPHY CXDI-401C WIRELESS
K
14
1192
DR 400
K
14
0235
XGEO GR40CW
K
14
0056
DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A
K
14
0060
DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A
K
14
0771
PHILIPS ELEVA WORKSPOT
K
13
3524
PVMED DDR 2430T
K
14
0646
DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G
K
13
3139
VIZION ULTRA
K
13
3782
NOVA FA DR SYSTEM
K
13
3442
BONE SUPPRESSION SOFTWARE
K
13
3409
DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA
K
13
2842
FLAATZ 600 SERIES (FLAATZ 600/601)
K
13
2921
GALAXY PLUS
K
13
3120
COMPUTED RADIOGRAPHY SCANNER
K
13
3106
COMPUTED RADIOGRAPHY SCANNER
K
13
2509
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
K
13
1211
DICOMPACS DX-R WITH FLAT PANEL
K
13
1483
PHILIPS PIXIUM 4343RC
K
13
1114
DIGITAL FLAT PANEL X-RAY DETECTOR
K
13
1408
CR 12-X DIGITIZER
K
13
0936
AERODR SYSTEM WITH P-31
K
13
1106
DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS,
K
13
0935
DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA
K
13
1314
DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)
K
13
0567
DR LONG LENGTH IMAGING SOFTWARE
K
13
0464
CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR
K
13
0377
KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
K
13
0883
SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T
K
12
3345
DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA
K
12
2736
DX-D IMAGING PACKAGE
K
12
3740
EOS
K
12
2865
VIVIX-S WIRELESS
K
12
2928
DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA
K
12
3644
VIZION + DR
K
12
2866
VIVIX-S WITH VXVUE
K
12
2919
DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA
K
12
3499
AEROPILOT
K
12
3005
DDRVERSA MOTION
K
12
2495
PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR
K
12
2173
DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC
K
12
2842
RADREX-I, SW V4.00 MODEL DRAD-3000E
K
12
0629
FDR GO FLEX
K
12
2182
DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC
K
12
1095
DX-D IMAGING PACKAGE
K
12
1948
CR 10-X DIGITIZER
K
12
1838
LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM
K
11
3449
FUSION FLAT PANEL
K
11
2527
UNIVERSAL DIGITAL INTERFACE (UDI) 1717
K
12
1132
EZSENSOR P DIGITAL INTRAORAL SENSOR
K
12
0020
VIVIX-S
K
11
3812
ATAL-8
K
11
1824
FLAT PANEL DETECTOR
K
10
2327
CLEARVISION DR 7000F
K
12
0477
AEROSYNC FOR AERODR SYSTEM
K
12
0721
EOS
K
12
0380
SATURN 8000
K
12
0131
REGIUS SIGMA2
K
11
1305
UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W
K
11
3630
DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA
K
11
2751
SDX-4343CS
K
11
3052
INFINIX-CCI
K
11
2132
KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
K
11
2558
DIGITAL FLAT PANEL X-RAY DETECTOR
K
11
2661
VIZION DR
K
10
3348
DIGIVIEW 250
K
11
1583
FLAATZ 560
K
11
1865
WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE
K
11
2309
DIGITAL RADIOGRAPHY
K
11
1682
DIGITAL RADIOGRAPHY
K
11
1548
WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE
K
11
0801
WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
K
11
1312
SANTEVIEW
K
10
3703
REGUIS SIGMA
K
10
2479
ALARA T210 COMPUTED RADIOGRAPHY SYSTEM
K
11
1098
INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN
K
10
2619
COMPUTED RADDIOGRAPHY SCANNER
K
10
3599
UNIVERSAL DIGITAL INTERFACE (UDI) 1717
K
11
0210
SATURN 8000-GS
K
10
3596
WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR
K
10
3591
DIGITAL RADIOGRAPHY
K
10
2474
FLAATZ 750E
K
10
2321
DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP
K
10
0703
STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS
K
10
2587
LLX240AB01
K
10
1590
DIGITAL FLAT PANEL X-RAY DETECTOR
K
10
2615
WIRELESS DR IMAGING OPTION-WDR1
K
10
2012
DIGITAL RADIOGRAPHY
K
09
1090
DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717
K
10
1289
SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB
K
10
0762
FLAT PANEL DETECTOR, MODEL FDR D-EVO
K
10
0001
MOBIVISION
K
09
3790
SIMONDR DRP
K
09
3427
FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR
K
09
2669
DX-D IMAGING PACKAGE
K
09
2717
DIRECT DIGITIZER, REGIUS MODEL 210
K
09
0742
DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A
K
09
2238
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS
K
08
2450
IDR
K
09
1545
DIGITAL RADIOGRAPHY CXDI-60C
K
09
1436
DIGITAL RADIOGRAPHY, MODEL CXDI-55C
K
09
1435
DIGITAL RADIOGRAPHY MODEL CXDI-55G
K
09
0672
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS
K
09
0062
WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
K
09
0318
CARESTREAM DRX-1 SYSTEM
K
09
0625
WIRELESS PORTABLE DETECTOR FD-W17
K
09
0623
DIGITAL RADIOGRAPHY CXDI-40G COMPACT
K
08
3224
CPI RAD VISION, MODEL VZW2944XX-YY
K
08
3645
RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS
K
08
2347
DIGITAL RADIOGRAPHY, FLEXDR C30
K
08
2494
DRAD3000E/RADREX-I
K
08
1963
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS
K
08
1648
DIGITAL RADIOGRAPHY CXDI-60G
K
08
1624
INFX-8000F (INFINIX CSI AND INFINIX DPI)
K
08
0589
SATURN 9000-810
K
07
3670
KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260
K
08
0064
FLAATZ 750
K
07
3165
DRAD-3000E, RADREX-I
K
07
2984
SATURN 9000-550
K
07
3056
DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9
K
07
2983
SATURN 9000-750
K
07
1682
CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER)
K
06
3710
SATURN 9000
K
07
1193
VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS
K
07
1181
DIRECT DIGITIZER, REGIUS MODEL 110
K
07
0829
SYNEPIX 4600 DETECTOR
K
07
1162
AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS
K
07
0563
VIDAR VISION 2000
K
07
0528
PHILIPS ESSENTA DR
K
07
0079
X3C DIGITAL RADIOGRAPHIC DETECTOR
K
06
3421
DX-SI
K
06
3283
DEFINIUM 5000 X-RAY SYSTEM
K
06
3039
XPLORER 2200 DIGITAL RADIOGRAPHIC SYSTEM
K
06
2376
DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI
K
06
2742
CR 85-X
K
06
2586
XPLORER 1600 PLUS
K
06
2390
CRYSTALVIEW R200
K
06
2223
AGFA MODEL CR30-X
K
06
2221
CXDI-40EC
K
06
1538
ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200
K
05
2661
QUIX DIGITAL RADIOGRAPHIC UPGRADE
K
06
1054
AXIOM ARISTOS FX PLUS
K
06
0137
KODAK ECLIPSE IMAGE PROCESSING SOFTWARE
K
06
0433
DIGITAL RADIOGRAPHY CXDI-50C
K
05
3634
COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION
K
05
3029
NDR+/DIVA-D
K
05
2938
CR-PRO
K
05
2095
MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190
K
05
1998
REGIUS MODEL 170 DIRECT DIGITIZER
K
05
1494
MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001
K
05
2136
GR17 DIGITAL DETECTOR
K
05
1418
DIRECT DIGITIZER REGIUS MODEL 370
K
04
2791
INSTANT-X, MODELS 1713 & 128
K
05
1483
KODAK DIRECTVIEW DR SYSTEM DETECTOR
K
05
0925
DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE
K
05
0718
DDRCOMBI TRAUMA
K
05
0987
DIGITAL RADIOGRAPHY MODEL CXDI-40EG
K
05
0810
AGFA CR50.0
K
04
2602
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING
K
04
2386
DIRECT DIGITIZER, REGIUS MODEL 190
K
04
2821
DIGITAL DETECTOR, MODEL GR17
K
04
2397
SCANX 14
K
04
2041
XPLORER 1600
K
04
2023
FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER
K
04
1701
AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM
K
03
3561
FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER
K
03
2210
ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM
K
03
1198
SCANX 10
K
03
1633
CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C
K
03
1447
CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G
K
02
4147
PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM
K
02
3750
CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G
K
02
3586
DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS
K
02
3061
KONICA DIRECT DIGITIZER REGIUS, MODEL 170
K
02
3124
CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT
K
02
1829
MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM
K
01
3897
SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW
K
02
0635
KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622; KODAK DIRECTVIEW CR 900 SYSTEM, CATALOG# 1170976
K
01
3054
KONICA DIRECT DIGITIZER REGIUS MODEL 350
K
01
3218
FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II
K
01
2750
ADC PEDIATRIC
K
00
3238
SOLID STATE X-RAY IMAGING DEVICES
K
01
3138
ADC COMPACT PLUS
K
00
3438
SMART RAD
K
00
1499
PHORMAX EAGLE SCANNER SYSTEM
K
00
3256
PCCR DIGITAL IMAGING DEVICE
K
99
2955
XPLORER 1000
K
99
3861
FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER
K
99
2794
STINGRAY DR, MODEL 1
K
99
2547
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22
K
99
0359
KONICA DIRECT DIGITIZER, MODEL DD-341
K
98
3732
THORAX FD AND MULTIX FD
K
98
2661
CDR - PAN MODEL 4700
K
98
2795
PHILIPS BUCKY VISION
K
98
1556
CANON X-RAY DIGITAL CAMERA CXDI-11
K
97
3206
STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY
MUA
Bone Sonometer
MUE
Full Field Digital, System, X-Ray, Mammographic
MUI
Media, Coupling, Ultrasound
MWP
Cabinet, X-Ray System
MYN
Analyzer, Medical Image
NCS
System, Imaging, Holography, Acoustic
NWE
Colon Computed Tomography System, Computer Aided Detection
OAS
X-Ray, Tomography, Computed, Dental
OEB
Lung Computed Tomography System, Computer-Aided Detection
OII
Arthrogram Tray
OIJ
Biopsy Needle Guide Kit
OIK
Radiology Dental Tray
OIL
Discography Kit
OIM
Mri Disposable Kit
OIO
Radiographic Contrast Tray
OIP
Radiology-Diagnostic Kit
OMJ
Chest X-Ray Computer Aided Detection
OQQ
Diagnostic Ultrasonic Transducer, Robotic
OUO
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
OWB
Interventional Fluoroscopic X-Ray System
OXO
Image-Intensified Fluoroscopic X-Ray System, Mobile
PGY
Display, Diagnostic Radiology
POK
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
QAS
Radiological Computer-Assisted Triage And Notification Software
QFM
Radiological Computer-Assisted Prioritization Software For Lesions
QHA
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
QHX
Fluoroscopic X-Ray Image Intensifier
QHY
Solid State Fluoroscopic X-Ray Imager
QIH
Automated Radiological Image Processing Software
QKB
Radiological Image Processing Software For Radiation Therapy
RCC
C-Arm Fluoroscopic X-Ray System
QTZ
Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
QXL
Cabinet, Emission Computed Tomography System
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart F—Therapeutic Devices
Subpart G—Miscellaneous Devices
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
RA
/
subpart-b—diagnostic-devices
/
MQB
/
K171716
View Source
SKR 3000
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171716
510(k) Type
Traditional
Applicant
Konica Minolta, Inc.
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
8/25/2017
Days to Decision
77 days
Submission Type
Statement