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Innolitics
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Review Panel
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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
MUA
Bone Sonometer
2
Product Code
MUE
Full Field Digital, System, X-Ray, Mammographic
2
Product Code
K
23
3539
MAMMOMAT B.brilliant
2
Cleared 510(K)
K
22
0073
RMF-2000
2
Cleared 510(K)
K
21
1720
Planmed Clarity 2D, Planmed Clarify S
2
Cleared 510(K)
K
21
2873
Aspire Cristalle
2
Cleared 510(K)
K
21
0151
Digimamo D
2
Cleared 510(K)
K
20
2822
Helianthus
2
Cleared 510(K)
K
21
1725
Senographe Pristina
2
Cleared 510(K)
K
21
1215
SenoBright HD
2
Cleared 510(K)
K
20
2902
2430MCA with Xmaru W
2
Cleared 510(K)
K
19
2317
Planmed Clarity 2D and Clarity S
2
Cleared 510(K)
K
20
0424
Giotto Class (Models - 3000X-YY and 4000X-YY)
2
Cleared 510(K)
K
19
3166
MAMMOMAT Revelation
2
Cleared 510(K)
K
19
3334
Pristina Serena Bright
2
Cleared 510(K)
K
19
0809
Sample Imaging for Senographe Pristina
2
Cleared 510(K)
K
18
2951
Pristina Serena 3D
2
Cleared 510(K)
K
17
3576
Pristina Serena
2
Cleared 510(K)
K
17
3408
Mammomat Revelation
2
Cleared 510(K)
K
16
3328
Planmed Clarity
2
Cleared 510(K)
K
17
2404
SenoBright HD
2
Cleared 510(K)
K
17
3132
ASPIRE Cristalle
2
Cleared 510(K)
K
17
2027
Adani MammoScan
2
Cleared 510(K)
K
16
3302
Senographe Pristina
2
Cleared 510(K)
K
17
0930
RSM 2430C
2
Cleared 510(K)
K
16
2670
RSM 1824C with RConsole1
2
Cleared 510(K)
K
16
3252
Mammomat Fusion with Stereotactic Biopsy
2
Cleared 510(K)
K
16
2268
Senographe Pristina
2
Cleared 510(K)
K
15
1645
MAMMOMAT Fusion
2
Cleared 510(K)
K
13
3972
ASPIRE CRISTALLE
2
Cleared 510(K)
K
13
0704
MICRODOSE SI
2
Cleared 510(K)
K
13
1885
SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)
2
Cleared 510(K)
K
12
3520
MAMMOMAT INSPIRATION PRIME
2
Cleared 510(K)
K
12
2510
ICRCO 3600M
2
Cleared 510(K)
K
12
2286
MAMMOMAL INSPIRATION
2
Cleared 510(K)
K
12
3995
MICRODOSE SI
2
Cleared 510(K)
K
12
3873
CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
2
Cleared 510(K)
K
12
1963
PLANMED NUANCE DIGIGUIDE
2
Cleared 510(K)
K
12
1674
ASPIRE HD PLUS, ASPIRE HD-S
2
Cleared 510(K)
K
12
0246
KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN)
2
Cleared 510(K)
K
12
0255
PHILIPS MICRODOSE
2
Cleared 510(K)
K
11
0717
KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM
2
Cleared 510(K)
K
11
1324
CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER
2
Cleared 510(K)
K
11
0798
SENOGRAPHE DS, SENOGRAPHE ESSENTIAL
2
Cleared 510(K)
K
11
1646
ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR
2
Cleared 510(K)
K
11
1434
GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L
2
Cleared 510(K)
K
10
3485
SENOGRAPH DS, SENOGRAPH ESSENSTIAL
2
Cleared 510(K)
K
11
1361
PLANMED NUANCE EXCEL
2
Cleared 510(K)
K
11
0572
MAMMODIAGNOST DR
2
Cleared 510(K)
K
11
0729
ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
Cleared 510(K)
K
11
0025
SECTRA MICRODOSE MAMMOGRAPHY
2
Cleared 510(K)
P
08
0018
KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE
2
PMA Approval
P
01
0025
HOLOGIC SELENIA DIMENSIONS 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
03
0010
SIEMENS MAMMOMAT INSPIRATION FULL - FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
08
0018
KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY
2
PMA Approval
P
03
0010
SIEMENS MAMMOMAT NOVATION FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM
2
PMA Approval
P
01
0025
HOLOGIC SELENIA DIMENSIONS 2D FULL DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
GE HEALTHCARE SENOGRAPHE ESSENTIAL DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
01
0025
SELENIA FFDM SYSTEM FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
01
0025
SELENIA DIMENSIONS 2D MOBILE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
05
0014
FULL FIELD DIGITAL MAMMOGRAPHY
2
PMA Approval
P
99
0066
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
03
0010
MAMMOMAT NOVATION DR
2
PMA Approval
P
01
0025
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
01
0025
HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
05
0014
FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE
2
PMA Approval
P
01
0025
SELENIA DIMENSIONS (2D) FFDM SYSTEM
2
PMA Approval
P
99
0066
GE HEALTHCARE SENOGRAPHE 2000D DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
01
0025
HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSYTEM (SENO ESSENTIAL
2
PMA Approval
P
01
0025
HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
SENOGRAPHE DS AND ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEMS
2
PMA Approval
P
99
0066
SENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
01
0025
HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
SENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS
2
PMA Approval
P
99
0066
SENOGRAPHE 2000D AND DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS
2
PMA Approval
P
99
0066
SENOGRAPHE ESSENTIAL SYSTEM
2
PMA Approval
P
05
0014
FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS)
2
PMA Approval
P
99
0066
SENOGRAPHE DS FFDM SYSTEM
2
PMA Approval
P
99
0066
SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
01
0025
HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
03
0010
SIEMENS MAMMOMAT NOVATION FULL FIELD DIGITAL MAMMOGRAPHY (FFDM)SYSTEM
2
PMA Approval
P
01
0017
FISCHER IMAGING CORPORATION SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
01
0025
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
SENOGRAPHE DS & 2000D FFDM SYSTEM
2
PMA Approval
P
03
0010
SIEMENS MAMMOMAT NOVATION FFDM SYSTEM
2
PMA Approval
P
99
0066
SENOGRAPHE DS & 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
03
0010
SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
01
0017
SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
01
0025
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
03
0010
SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
01
0017
SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
01
0025
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
01
0025
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
01
0025
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
SENOGRAPHE
2
PMA Approval
P
01
0025
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMOGRAPHY SYSTEM
2
PMA Approval
P
01
0025
LORAD DIGITAL BREAST IMAGER
2
PMA Approval
P
99
0066
GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
MOBILE SENOGRAPHE 2000D
2
PMA Approval
P
99
0066
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
01
0017
SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
SENOGRAPHE 2000 D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
SENOGRAPHE 2000 D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
P
99
0066
GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
2
PMA Approval
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
/
MUE
/
K110572
View Source
MAMMODIAGNOST DR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K110572
510(k) Type
Traditional
Applicant
PHILIPS MEDICAL SYSTEMS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/23/2011
Days to Decision
206 days
Submission Type
Summary
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)
MUA
Bone Sonometer
MUE
Full Field Digital, System, X-Ray, Mammographic
K
23
3539
MAMMOMAT B.brilliant
K
22
0073
RMF-2000
K
21
1720
Planmed Clarity 2D, Planmed Clarify S
K
21
2873
Aspire Cristalle
K
21
0151
Digimamo D
K
20
2822
Helianthus
K
21
1725
Senographe Pristina
K
21
1215
SenoBright HD
K
20
2902
2430MCA with Xmaru W
K
19
2317
Planmed Clarity 2D and Clarity S
K
20
0424
Giotto Class (Models - 3000X-YY and 4000X-YY)
K
19
3166
MAMMOMAT Revelation
K
19
3334
Pristina Serena Bright
K
19
0809
Sample Imaging for Senographe Pristina
K
18
2951
Pristina Serena 3D
K
17
3576
Pristina Serena
K
17
3408
Mammomat Revelation
K
16
3328
Planmed Clarity
K
17
2404
SenoBright HD
K
17
3132
ASPIRE Cristalle
K
17
2027
Adani MammoScan
K
16
3302
Senographe Pristina
K
17
0930
RSM 2430C
K
16
2670
RSM 1824C with RConsole1
K
16
3252
Mammomat Fusion with Stereotactic Biopsy
K
16
2268
Senographe Pristina
K
15
1645
MAMMOMAT Fusion
K
13
3972
ASPIRE CRISTALLE
K
13
0704
MICRODOSE SI
K
13
1885
SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)
K
12
3520
MAMMOMAT INSPIRATION PRIME
K
12
2510
ICRCO 3600M
K
12
2286
MAMMOMAL INSPIRATION
K
12
3995
MICRODOSE SI
K
12
3873
CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
K
12
1963
PLANMED NUANCE DIGIGUIDE
K
12
1674
ASPIRE HD PLUS, ASPIRE HD-S
K
12
0246
KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN)
K
12
0255
PHILIPS MICRODOSE
K
11
0717
KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM
K
11
1324
CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER
K
11
0798
SENOGRAPHE DS, SENOGRAPHE ESSENTIAL
K
11
1646
ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR
K
11
1434
GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L
K
10
3485
SENOGRAPH DS, SENOGRAPH ESSENSTIAL
K
11
1361
PLANMED NUANCE EXCEL
K
11
0572
MAMMODIAGNOST DR
K
11
0729
ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM
K
11
0025
SECTRA MICRODOSE MAMMOGRAPHY
P
08
0018
KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE
P
01
0025
HOLOGIC SELENIA DIMENSIONS 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
P
03
0010
SIEMENS MAMMOMAT INSPIRATION FULL - FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
08
0018
KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY
P
03
0010
SIEMENS MAMMOMAT NOVATION FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM
P
01
0025
HOLOGIC SELENIA DIMENSIONS 2D FULL DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
GE HEALTHCARE SENOGRAPHE ESSENTIAL DIGITAL MAMMOGRAPHY SYSTEM
P
01
0025
SELENIA FFDM SYSTEM FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
01
0025
SELENIA DIMENSIONS 2D MOBILE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
P
05
0014
FULL FIELD DIGITAL MAMMOGRAPHY
P
99
0066
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
P
03
0010
MAMMOMAT NOVATION DR
P
01
0025
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
01
0025
HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
05
0014
FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE
P
01
0025
SELENIA DIMENSIONS (2D) FFDM SYSTEM
P
99
0066
GE HEALTHCARE SENOGRAPHE 2000D DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
P
01
0025
HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSYTEM (SENO ESSENTIAL
P
01
0025
HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
SENOGRAPHE DS AND ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEMS
P
99
0066
SENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
01
0025
HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
SENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS
P
99
0066
SENOGRAPHE 2000D AND DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS
P
99
0066
SENOGRAPHE ESSENTIAL SYSTEM
P
05
0014
FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS)
P
99
0066
SENOGRAPHE DS FFDM SYSTEM
P
99
0066
SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
01
0025
HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
03
0010
SIEMENS MAMMOMAT NOVATION FULL FIELD DIGITAL MAMMOGRAPHY (FFDM)SYSTEM
P
01
0017
FISCHER IMAGING CORPORATION SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
01
0025
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
SENOGRAPHE DS & 2000D FFDM SYSTEM
P
03
0010
SIEMENS MAMMOMAT NOVATION FFDM SYSTEM
P
99
0066
SENOGRAPHE DS & 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
03
0010
SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
01
0017
SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
01
0025
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
03
0010
SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
01
0017
SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
01
0025
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
01
0025
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
01
0025
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
SENOGRAPHE
P
01
0025
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMOGRAPHY SYSTEM
P
01
0025
LORAD DIGITAL BREAST IMAGER
P
99
0066
GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
MOBILE SENOGRAPHE 2000D
P
99
0066
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
01
0017
SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
SENOGRAPHE 2000 D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
SENOGRAPHE 2000 D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
P
99
0066
GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
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
/
MUE
/
K110572
View Source
MAMMODIAGNOST DR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K110572
510(k) Type
Traditional
Applicant
PHILIPS MEDICAL SYSTEMS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/23/2011
Days to Decision
206 days
Submission Type
Summary