FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
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Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
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Physical Medicine
Review Panel
Radiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
FCD
Barium Enema Kit
1
Product Code
ITZ
Assembly, Tube Housing, X-Ray, Therapeutic
2
Product Code
IWA
Source, Wire, Iridium, Radioactive
2
Product Code
IWB
System, Radiation Therapy, Radionuclide
2
Product Code
IWD
Device, Beam Limiting, Teletherapy, Radionuclide
2
Product Code
IWE
Monitor, Patient Position, Light-Beam
1
Product Code
IWF
Needle, Isotope, Gold, Titanium, Platinum
2
Product Code
IWG
Seed, Isotope, Gold, Titanium, Platinum
2
Product Code
IWH
Source, Teletherapy, Radionuclide
1
Product Code
IWI
Source, Isotope, Sealed, Gold, Titanium, Platinum
2
Product Code
IWJ
System, Applicator, Radionuclide, Manual
1
Product Code
IWK
Cyclotron, Medical
2
Product Code
IWL
System, Radiation Therapy, Neutron, Medical
2
Product Code
IWM
Synchrotron, Medical
2
Product Code
IXI
Block, Beam-Shaping, Radiation Therapy
2
Product Code
IYC
Generator, Orthovoltage, Therapeutic X-Ray
2
Product Code
IYD
Generator, Low Voltage, Therapeutic X-Ray
2
Product Code
IYE
Accelerator, Linear, Medical
2
Product Code
IYG
Betatron, Medical
2
Product Code
IYH
Generator, Dermatological (Grenz Ray), Therapeutic X-Ray
2
Product Code
IYI
Collimator, Orthovoltage, Therapeutic X-Ray
2
Product Code
IYJ
Collimator, Low Voltage, Therapeutic X-Ray
2
Product Code
IYK
Collimator, High Voltage, Therapeutic X-Ray
2
Product Code
IYL
Collimator, Dermatological, Therapeutic X-Ray
2
Product Code
JAD
System, Therapeutic, X-Ray
2
Product Code
JAE
Microtron, Medical
2
Product Code
JAI
Couch, Radiation Therapy, Powered
2
Product Code
JAQ
System, Applicator, Radionuclide, Remote-Controlled
2
Product Code
KPQ
System, Simulation, Radiation Therapy
2
Product Code
KPZ
Generator, High Voltage, X-Ray, Therapeutic
2
Product Code
KQA
Device, Beam Limiting, X-Ray, Therapeutic
2
Product Code
KXK
Source, Brachytherapy, Radionuclide
2
Product Code
LHN
System, Radiation Therapy, Charged-Particle, Medical
2
Product Code
MUJ
System, Planning, Radiation Therapy Treatment
2
Product Code
K
24
3057
TrueFit Bolus; TrueFlex Bolus
2
Cleared 510(K)
K
24
1876
Vitesse (5.0)
2
Cleared 510(K)
K
24
1318
Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)
2
Cleared 510(K)
K
23
3236
Radiance V5
2
Cleared 510(K)
K
23
2799
syngo.via RT Image Suite
2
Cleared 510(K)
K
23
4068
ART-Plan (v.2.2.0)
2
Cleared 510(K)
K
23
2479
ART-Plan
2
Cleared 510(K)
K
23
1825
Panther TPS
2
Cleared 510(K)
K
23
2400
VariSeed (v10)
2
Cleared 510(K)
K
22
3724
MOZI TPS
2
Cleared 510(K)
K
23
0557
Eclipse Treatment Planning System (v18.0)
2
Cleared 510(K)
K
22
2728
Radiation Planning Assistant (RPA)
2
Cleared 510(K)
K
22
2312
RayStation 12A
2
Cleared 510(K)
K
22
3279
RT Elements (4.0)
2
Cleared 510(K)
K
22
3233
Monaco RTP System
2
Cleared 510(K)
K
22
2803
Oncospace
2
Cleared 510(K)
K
22
0783
syngo.via RT Image Suite
2
Cleared 510(K)
K
21
1841
MRI Planner
2
Cleared 510(K)
K
22
0582
ClearCalc Model RADCA V2
2
Cleared 510(K)
K
21
3787
Monaco RTP System
2
Cleared 510(K)
K
22
0141
RayStation 11B
2
Cleared 510(K)
K
21
2274
INT Contour
2
Cleared 510(K)
K
21
4081
MRCAT Head & Neck
2
Cleared 510(K)
K
21
3438
3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory
2
Cleared 510(K)
K
21
1867
RayStation 11.0
2
Cleared 510(K)
K
21
1881
AI Segmentation
2
Cleared 510(K)
K
21
1379
syngo.via RT Image Suite
2
Cleared 510(K)
K
21
1511
decimal Bolus
2
Cleared 510(K)
K
21
0645
RayStation 10.1
2
Cleared 510(K)
K
21
1034
Corvus Radiation Therapy Planning System
2
Cleared 510(K)
K
20
3469
AI Segmentation
2
Cleared 510(K)
K
20
3681
RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review
2
Cleared 510(K)
K
20
2284
Oncospace
2
Cleared 510(K)
K
20
2789
Monaco Rtp System
2
Cleared 510(K)
K
20
3766
4D Integrated Treatment Console
2
Cleared 510(K)
K
20
0569
RayStation
2
Cleared 510(K)
K
20
1350
CORVUS
2
Cleared 510(K)
K
20
1444
Syngo.via RT Image Suite
2
Cleared 510(K)
K
20
1607
Eclipse Treatment Planning System v16.1
2
Cleared 510(K)
K
20
0487
RayCare 3.1
2
Cleared 510(K)
K
19
3459
Panther Stereotactic
2
Cleared 510(K)
K
19
3640
ClearCalc
2
Cleared 510(K)
K
20
0608
Eclipse Treatment Planning System v16.0
2
Cleared 510(K)
K
19
3109
MRCAT brain
2
Cleared 510(K)
K
19
3381
RadCalc Software
2
Cleared 510(K)
K
19
2554
decimal3D
2
Cleared 510(K)
K
19
2065
Syngo.Via RT Image Suite
2
Cleared 510(K)
K
19
1384
RayCare 2.3
2
Cleared 510(K)
K
19
0387
RayStation
2
Cleared 510(K)
K
18
2888
MRCAT Pelvis
2
Cleared 510(K)
K
19
0664
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
2
Cleared 510(K)
K
19
0178
Monaco RTP System
2
Cleared 510(K)
K
18
2665
Sensus TPS Workstation
2
Cleared 510(K)
K
18
3037
Monaco RTP System
2
Cleared 510(K)
K
18
0289
3D Bolus Software
2
Cleared 510(K)
K
18
1145
Eclipse Treatment Planning System
2
Cleared 510(K)
K
17
3940
Astroid Planning App
2
Cleared 510(K)
K
18
0379
RayStation 7
2
Cleared 510(K)
K
18
0308
Prelude
2
Cleared 510(K)
K
17
3635
syngo.via RT Image Suite
2
Cleared 510(K)
K
17
0750
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
2
Cleared 510(K)
K
17
2163
Eclipse Treatment Planning System
2
Cleared 510(K)
K
17
1885
Radiance V4
2
Cleared 510(K)
K
17
0969
Eclipse Treatment Planning System
2
Cleared 510(K)
K
17
1536
RayStation
2
Cleared 510(K)
K
17
0355
RayStation 6
2
Cleared 510(K)
K
17
0086
Pinnacle Radiation Therapy Planning System
2
Cleared 510(K)
K
16
2370
syngo.via RT Image Suite
2
Cleared 510(K)
K
16
1136
Precision Treatment Planning System
2
Cleared 510(K)
K
16
0093
RayStation
2
Cleared 510(K)
K
15
1435
MRCAT
2
Cleared 510(K)
K
15
3368
Radiance V3
2
Cleared 510(K)
K
14
3514
Panther StereoSeed
2
Cleared 510(K)
K
15
1469
CORVUS Radiation Therapy Planning System
2
Cleared 510(K)
K
15
2488
Onrad Treatment System
2
Cleared 510(K)
K
15
2393
Eclipse Treatment Planning System
2
Cleared 510(K)
K
15
1887
syngo VSim
2
Cleared 510(K)
K
15
1560
QuickPlan
2
Cleared 510(K)
K
15
1666
Leksell GammaPlan
2
Cleared 510(K)
K
15
1380
syngo.via RT Image Suite
2
Cleared 510(K)
K
15
1369
.decimal p.d
2
Cleared 510(K)
K
15
1233
Monaco
2
Cleared 510(K)
K
14
1900
SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE
2
Cleared 510(K)
K
15
0547
.decimal Astroid Dosimetry App
2
Cleared 510(K)
K
14
3269
Delivery Analysis
2
Cleared 510(K)
K
14
2108
RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS
2
Cleared 510(K)
K
14
1860
RAYSTATION
2
Cleared 510(K)
K
14
1248
SMART SEGMENTATION KNOWLEDGE BASED CONTOURING
2
Cleared 510(K)
K
14
1283
ECLIPSE TREATMENT PLANNING SYSTEM
2
Cleared 510(K)
K
13
2816
ONCENTRA BRACHY
2
Cleared 510(K)
K
14
0187
RAY STATION
2
Cleared 510(K)
K
13
3247
ECLIPSE TREATMENT PLANNING SYSTEM
2
Cleared 510(K)
K
13
3655
RADIANCE V2
2
Cleared 510(K)
K
13
3331
4D INTEGRATED TREATMENT CONSOLE
2
Cleared 510(K)
K
13
2971
MONACO
2
Cleared 510(K)
K
13
1891
ECLIPSE TREATMENT PLANNING SYSTEM
2
Cleared 510(K)
K
13
1428
RADVISION
2
Cleared 510(K)
K
13
0617
RAYSTATION
2
Cleared 510(K)
K
12
3263
HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS
2
Cleared 510(K)
K
12
3357
ONQ RTS
2
Cleared 510(K)
K
12
3152
VITESSE 3.0
2
Cleared 510(K)
K
12
1448
ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY
2
Cleared 510(K)
K
12
0551
SIMUPLAN TREATMENT PLANNING SYSTEM
2
Cleared 510(K)
K
12
0387
RAYSTATION
2
Cleared 510(K)
K
12
0363
SYNGO RT INTERFACE
2
Cleared 510(K)
K
11
2723
EPIGRAY
2
Cleared 510(K)
K
11
2060
RADIANCE
2
Cleared 510(K)
K
11
2776
TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER
2
Cleared 510(K)
K
11
3102
ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING
2
Cleared 510(K)
K
11
1311
SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING
2
Cleared 510(K)
K
11
2446
TOMOTHERAPY TREATMENT SYSTEM
2
Cleared 510(K)
K
10
3515
EQUAL DOSE
2
Cleared 510(K)
K
11
0730
MONACO RTP SYSTEM
2
Cleared 510(K)
K
10
3246
IPLAN RT
2
Cleared 510(K)
K
10
3146
ISOGRAY TREATMENT PLANNING SYSTEM
2
Cleared 510(K)
K
10
2915
VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM
2
Cleared 510(K)
K
10
3093
LEKSELL GAMMAPLAN
2
Cleared 510(K)
K
10
1220
EXPLORER 4D TREATMENT PLANNING SYSTEM
2
Cleared 510(K)
K
10
2216
XIO RTP SYSTEM
2
Cleared 510(K)
K
10
2011
ECLIPSE TREATMENT PLANNING SYSTEM
2
Cleared 510(K)
K
10
1076
PROWESS PANTHER PROARC, MODEL VERSION 5.0
2
Cleared 510(K)
K
10
1119
SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864
2
Cleared 510(K)
K
10
0056
MEDCOM RT-VIEWER SYSTEM
2
Cleared 510(K)
K
10
0417
XKNIFE 5
2
Cleared 510(K)
K
10
0552
RAYSTATION VERSION 1.0
2
Cleared 510(K)
K
10
0092
CORVUS RADIATION THERAPY PLANNING SYSTEM
2
Cleared 510(K)
K
09
3588
EXPLORER 4D TREATMENT PLANNING SYSTEM
2
Cleared 510(K)
K
09
3391
SIMUPLAN TREATMENT PLANNING SYSTEM
2
Cleared 510(K)
K
09
2928
DOSE VOLUME HISTOGRAM (DVH) EVALUATOR
2
Cleared 510(K)
K
09
2132
XIO RTP SYSTEM
2
Cleared 510(K)
K
09
0972
LEKSELL GAMMAPLAN
2
Cleared 510(K)
K
09
1179
MONACO RTP SYSTEM, VMAT OPTION
2
Cleared 510(K)
K
09
0893
TIGRT TPS
2
Cleared 510(K)
K
09
1492
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
2
Cleared 510(K)
K
09
1145
FLEXIPLAN 3D AND 3D+
2
Cleared 510(K)
K
09
0531
RADCALC SOFTWARE, VERSION 6.0
2
Cleared 510(K)
K
08
3502
PANTHER REALART, MODEL 4.7
2
Cleared 510(K)
K
09
0182
MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS)
2
Cleared 510(K)
K
09
1146
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
2
Cleared 510(K)
K
08
3672
P.D SOFTWARE
2
Cleared 510(K)
K
09
0808
PINNACLE3 SMARTARC
2
Cleared 510(K)
K
08
3414
RADIONICS XKNIFE HDRT SYSTEM
2
Cleared 510(K)
K
08
3264
RAYAUTOPLAN 1.0
2
Cleared 510(K)
K
08
2606
COMMISSIONING DATA MANAGEMENT SYSTEM (CDMS)
2
Cleared 510(K)
K
08
2642
ONCENTRA RT VIEWER 1.0
2
Cleared 510(K)
K
08
2221
RAYDOSE
2
Cleared 510(K)
K
08
2005
MODIFICATION TO HI-ART TREATMENT SYSTEM
2
Cleared 510(K)
K
08
1112
FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM
2
Cleared 510(K)
K
08
0888
MODEIFICATION TO IPLAN RT DOSE
2
Cleared 510(K)
K
08
0601
ERGO++ VERSION 1.7
2
Cleared 510(K)
K
08
1281
OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)
2
Cleared 510(K)
K
08
0929
ONCENTRA GYN
2
Cleared 510(K)
K
07
3020
ECLIPSE TREATMENT PLANNING SYSTEM
2
Cleared 510(K)
K
07
1760
MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM
2
Cleared 510(K)
K
07
1938
MONACO RTP SYSTEM
2
Cleared 510(K)
K
07
1873
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
2
Cleared 510(K)
K
06
3230
INTEGRA RADIONICS IMAGEFUSION 3
2
Cleared 510(K)
K
06
3482
CROSSPLAN / ACCUSOFT-XL V.4.04
2
Cleared 510(K)
K
06
2967
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
2
Cleared 510(K)
K
06
2032
ACCUSOFT, ACCUSOFT XL
2
Cleared 510(K)
K
06
2514
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
2
Cleared 510(K)
K
06
1893
INTEGRA RADIONICS XKNIFE RT 4
2
Cleared 510(K)
K
05
3584
IPLAN RT DOSE
2
Cleared 510(K)
K
06
1440
P.D
2
Cleared 510(K)
K
06
1097
COHERENCE DOSIMETRIST, MODEL 2.2
2
Cleared 510(K)
K
05
0296
ECLIPSE TREATMENT PLANNING SYSTEM
2
Cleared 510(K)
K
05
2325
CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
2
Cleared 510(K)
K
05
1941
CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM
2
Cleared 510(K)
K
05
1497
VITESSE 2.0
2
Cleared 510(K)
K
04
1971
WIMRT MODULE FOR ARTP PLANNING SYSTEM
2
Cleared 510(K)
K
04
2861
ODYSSEY
2
Cleared 510(K)
K
04
2739
HI-ART SYSTEM
2
Cleared 510(K)
K
04
2269
LEKSELL GAMMAPLAN 4C WITH MULTIVIEW
2
Cleared 510(K)
K
04
1997
RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE
2
Cleared 510(K)
K
04
1403
ECLIPSE WITH AAA
2
Cleared 510(K)
K
03
1088
TRIMED PLAN, VERSION 2.2
2
Cleared 510(K)
K
04
1719
ONCENTRA-VISIR
2
Cleared 510(K)
K
04
0474
ACCUSOFT
2
Cleared 510(K)
K
04
0688
STANDARD IMAGING E.IMRT CALCULATOR
2
Cleared 510(K)
K
03
1281
ERGO SRS
2
Cleared 510(K)
K
03
2456
PROWESS
2
Cleared 510(K)
K
03
2724
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
2
Cleared 510(K)
K
03
0821
SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5
2
Cleared 510(K)
K
03
2345
CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY
2
Cleared 510(K)
K
03
2209
NOMOS CORVUS 5.0M
2
Cleared 510(K)
K
03
1349
OTP 1.2
2
Cleared 510(K)
K
02
2961
RTDOSEPLAN
2
Cleared 510(K)
K
02
2036
SIEMENS VIRTUAL SIMULATION (VSIM)
2
Cleared 510(K)
K
02
2741
SPOT PRO (220V), MODEL 131.099
2
Cleared 510(K)
K
02
2307
KONRAD, MODEL V.2.0
2
Cleared 510(K)
K
02
0027
FOCUS RADIATION TREATMENT PLANNING SYSTEM
2
Cleared 510(K)
K
02
2411
PRECISEPLAN 2.0
2
Cleared 510(K)
K
01
3644
ACQPLAN 5.0
2
Cleared 510(K)
K
02
0971
DCM 2.0
2
Cleared 510(K)
K
02
1268
ECLIPSE, HELIOS OPTION
2
Cleared 510(K)
K
01
2575
PREFERNCE IMRT TREATMENT PLANNING MODULE
2
Cleared 510(K)
K
01
3673
HI-ART SYSTEM
2
Cleared 510(K)
K
01
3535
EVTOOL MODEL # V. 1.0
2
Cleared 510(K)
K
01
3112
FOCAL SIM
2
Cleared 510(K)
K
01
3661
XPLAN 2.2 WITH THE BODY SYSTEM
2
Cleared 510(K)
K
00
2132
ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS
2
Cleared 510(K)
K
01
2017
VARISEED 7.0
2
Cleared 510(K)
K
01
0682
HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM
2
Cleared 510(K)
K
01
1246
DCM 1.0
2
Cleared 510(K)
K
01
0784
PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1
2
Cleared 510(K)
K
00
2237
P3IMRT TM
2
Cleared 510(K)
K
00
2509
NOVALIS (SHAPED BEAM SURGERY SYSTEM)
2
Cleared 510(K)
K
00
1295
PIPER
2
Cleared 510(K)
K
00
2147
FOCUS
2
Cleared 510(K)
K
99
3675
PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM
2
Cleared 510(K)
K
00
2312
PROTON VISION 7.0
2
Cleared 510(K)
K
00
2240
RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0
2
Cleared 510(K)
K
99
4413
BRAINSCAN
2
Cleared 510(K)
K
00
1700
XPLAN 2.1
2
Cleared 510(K)
K
99
3895
OPTIRAD
2
Cleared 510(K)
K
00
0922
PROTON VISION
2
Cleared 510(K)
K
99
3923
ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM
2
Cleared 510(K)
K
99
2303
SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0
2
Cleared 510(K)
K
99
2762
BRACHYVISION 6.0
2
Cleared 510(K)
K
99
2434
ITP, MODEL 1.0
2
Cleared 510(K)
K
99
3766
HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM
2
Cleared 510(K)
K
99
0475
TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5
2
Cleared 510(K)
K
99
2864
RENDER-PLAN 3-D
2
Cleared 510(K)
K
99
2753
CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM
2
Cleared 510(K)
K
99
1237
XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL
2
Cleared 510(K)
K
99
1815
EXPLORER 3D
2
Cleared 510(K)
K
98
4532
CADPLAN HELIOS OPTION 6.0
2
Cleared 510(K)
K
98
3343
PLATO BRACHYTHERAPHY, MODEL V. 14.0
2
Cleared 510(K)
K
98
2696
INTERPLANT
2
Cleared 510(K)
K
99
0071
IMAGEFUSION 2.0
2
Cleared 510(K)
K
98
2791
ROCS TPS
2
Cleared 510(K)
K
98
4196
MODIFICATION TO PROWESS PRO-SIM
2
Cleared 510(K)
K
98
1678
STRATA, MODEL V.O.95
2
Cleared 510(K)
K
98
2821
MMS THERPACPLUS B3DTUI MODEL NUMBER 6.7
2
Cleared 510(K)
K
97
4770
ACQPLAN
2
Cleared 510(K)
K
91
5691
FOCUS RTP
2
Cleared 510(K)
MWW
Accessory - Film Dosimetry System
2
Product Code
NMP
Needle, Isotope, Reprocessed
2
Product Code
NZT
Dosimeter, Ionizing Radiation, Implanted
2
Product Code
OIN
Prostate Seeding Kit
2
Product Code
ONL
Conformal Brachytherapy Source
2
Product Code
OVB
Hydrogel Spacer
2
Product Code
PCT
Prostate Immobilizer Rectal Balloon
2
Product Code
RGC
X-Ray Field Indicator Light (Laser)
1
Product Code
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 30 November 2024 at 11:09 am
RA
/
subpart-f—therapeutic-devices
/
MUJ
/
K190387
View Source
RayStation
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190387
510(k) Type
Traditional
Applicant
RaySearch Laboratories AB (publ)
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
6/19/2019
Days to Decision
120 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
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart F—Therapeutic Devices
FCD
Barium Enema Kit
ITZ
Assembly, Tube Housing, X-Ray, Therapeutic
IWA
Source, Wire, Iridium, Radioactive
IWB
System, Radiation Therapy, Radionuclide
IWD
Device, Beam Limiting, Teletherapy, Radionuclide
IWE
Monitor, Patient Position, Light-Beam
IWF
Needle, Isotope, Gold, Titanium, Platinum
IWG
Seed, Isotope, Gold, Titanium, Platinum
IWH
Source, Teletherapy, Radionuclide
IWI
Source, Isotope, Sealed, Gold, Titanium, Platinum
IWJ
System, Applicator, Radionuclide, Manual
IWK
Cyclotron, Medical
IWL
System, Radiation Therapy, Neutron, Medical
IWM
Synchrotron, Medical
IXI
Block, Beam-Shaping, Radiation Therapy
IYC
Generator, Orthovoltage, Therapeutic X-Ray
IYD
Generator, Low Voltage, Therapeutic X-Ray
IYE
Accelerator, Linear, Medical
IYG
Betatron, Medical
IYH
Generator, Dermatological (Grenz Ray), Therapeutic X-Ray
IYI
Collimator, Orthovoltage, Therapeutic X-Ray
IYJ
Collimator, Low Voltage, Therapeutic X-Ray
IYK
Collimator, High Voltage, Therapeutic X-Ray
IYL
Collimator, Dermatological, Therapeutic X-Ray
JAD
System, Therapeutic, X-Ray
JAE
Microtron, Medical
JAI
Couch, Radiation Therapy, Powered
JAQ
System, Applicator, Radionuclide, Remote-Controlled
KPQ
System, Simulation, Radiation Therapy
KPZ
Generator, High Voltage, X-Ray, Therapeutic
KQA
Device, Beam Limiting, X-Ray, Therapeutic
KXK
Source, Brachytherapy, Radionuclide
LHN
System, Radiation Therapy, Charged-Particle, Medical
MUJ
System, Planning, Radiation Therapy Treatment
K
24
3057
TrueFit Bolus; TrueFlex Bolus
K
24
1876
Vitesse (5.0)
K
24
1318
Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)
K
23
3236
Radiance V5
K
23
2799
syngo.via RT Image Suite
K
23
4068
ART-Plan (v.2.2.0)
K
23
2479
ART-Plan
K
23
1825
Panther TPS
K
23
2400
VariSeed (v10)
K
22
3724
MOZI TPS
K
23
0557
Eclipse Treatment Planning System (v18.0)
K
22
2728
Radiation Planning Assistant (RPA)
K
22
2312
RayStation 12A
K
22
3279
RT Elements (4.0)
K
22
3233
Monaco RTP System
K
22
2803
Oncospace
K
22
0783
syngo.via RT Image Suite
K
21
1841
MRI Planner
K
22
0582
ClearCalc Model RADCA V2
K
21
3787
Monaco RTP System
K
22
0141
RayStation 11B
K
21
2274
INT Contour
K
21
4081
MRCAT Head & Neck
K
21
3438
3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory
K
21
1867
RayStation 11.0
K
21
1881
AI Segmentation
K
21
1379
syngo.via RT Image Suite
K
21
1511
decimal Bolus
K
21
0645
RayStation 10.1
K
21
1034
Corvus Radiation Therapy Planning System
K
20
3469
AI Segmentation
K
20
3681
RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review
K
20
2284
Oncospace
K
20
2789
Monaco Rtp System
K
20
3766
4D Integrated Treatment Console
K
20
0569
RayStation
K
20
1350
CORVUS
K
20
1444
Syngo.via RT Image Suite
K
20
1607
Eclipse Treatment Planning System v16.1
K
20
0487
RayCare 3.1
K
19
3459
Panther Stereotactic
K
19
3640
ClearCalc
K
20
0608
Eclipse Treatment Planning System v16.0
K
19
3109
MRCAT brain
K
19
3381
RadCalc Software
K
19
2554
decimal3D
K
19
2065
Syngo.Via RT Image Suite
K
19
1384
RayCare 2.3
K
19
0387
RayStation
K
18
2888
MRCAT Pelvis
K
19
0664
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
K
19
0178
Monaco RTP System
K
18
2665
Sensus TPS Workstation
K
18
3037
Monaco RTP System
K
18
0289
3D Bolus Software
K
18
1145
Eclipse Treatment Planning System
K
17
3940
Astroid Planning App
K
18
0379
RayStation 7
K
18
0308
Prelude
K
17
3635
syngo.via RT Image Suite
K
17
0750
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
K
17
2163
Eclipse Treatment Planning System
K
17
1885
Radiance V4
K
17
0969
Eclipse Treatment Planning System
K
17
1536
RayStation
K
17
0355
RayStation 6
K
17
0086
Pinnacle Radiation Therapy Planning System
K
16
2370
syngo.via RT Image Suite
K
16
1136
Precision Treatment Planning System
K
16
0093
RayStation
K
15
1435
MRCAT
K
15
3368
Radiance V3
K
14
3514
Panther StereoSeed
K
15
1469
CORVUS Radiation Therapy Planning System
K
15
2488
Onrad Treatment System
K
15
2393
Eclipse Treatment Planning System
K
15
1887
syngo VSim
K
15
1560
QuickPlan
K
15
1666
Leksell GammaPlan
K
15
1380
syngo.via RT Image Suite
K
15
1369
.decimal p.d
K
15
1233
Monaco
K
14
1900
SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE
K
15
0547
.decimal Astroid Dosimetry App
K
14
3269
Delivery Analysis
K
14
2108
RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS
K
14
1860
RAYSTATION
K
14
1248
SMART SEGMENTATION KNOWLEDGE BASED CONTOURING
K
14
1283
ECLIPSE TREATMENT PLANNING SYSTEM
K
13
2816
ONCENTRA BRACHY
K
14
0187
RAY STATION
K
13
3247
ECLIPSE TREATMENT PLANNING SYSTEM
K
13
3655
RADIANCE V2
K
13
3331
4D INTEGRATED TREATMENT CONSOLE
K
13
2971
MONACO
K
13
1891
ECLIPSE TREATMENT PLANNING SYSTEM
K
13
1428
RADVISION
K
13
0617
RAYSTATION
K
12
3263
HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS
K
12
3357
ONQ RTS
K
12
3152
VITESSE 3.0
K
12
1448
ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY
K
12
0551
SIMUPLAN TREATMENT PLANNING SYSTEM
K
12
0387
RAYSTATION
K
12
0363
SYNGO RT INTERFACE
K
11
2723
EPIGRAY
K
11
2060
RADIANCE
K
11
2776
TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER
K
11
3102
ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING
K
11
1311
SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING
K
11
2446
TOMOTHERAPY TREATMENT SYSTEM
K
10
3515
EQUAL DOSE
K
11
0730
MONACO RTP SYSTEM
K
10
3246
IPLAN RT
K
10
3146
ISOGRAY TREATMENT PLANNING SYSTEM
K
10
2915
VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM
K
10
3093
LEKSELL GAMMAPLAN
K
10
1220
EXPLORER 4D TREATMENT PLANNING SYSTEM
K
10
2216
XIO RTP SYSTEM
K
10
2011
ECLIPSE TREATMENT PLANNING SYSTEM
K
10
1076
PROWESS PANTHER PROARC, MODEL VERSION 5.0
K
10
1119
SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864
K
10
0056
MEDCOM RT-VIEWER SYSTEM
K
10
0417
XKNIFE 5
K
10
0552
RAYSTATION VERSION 1.0
K
10
0092
CORVUS RADIATION THERAPY PLANNING SYSTEM
K
09
3588
EXPLORER 4D TREATMENT PLANNING SYSTEM
K
09
3391
SIMUPLAN TREATMENT PLANNING SYSTEM
K
09
2928
DOSE VOLUME HISTOGRAM (DVH) EVALUATOR
K
09
2132
XIO RTP SYSTEM
K
09
0972
LEKSELL GAMMAPLAN
K
09
1179
MONACO RTP SYSTEM, VMAT OPTION
K
09
0893
TIGRT TPS
K
09
1492
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
K
09
1145
FLEXIPLAN 3D AND 3D+
K
09
0531
RADCALC SOFTWARE, VERSION 6.0
K
08
3502
PANTHER REALART, MODEL 4.7
K
09
0182
MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS)
K
09
1146
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K
08
3672
P.D SOFTWARE
K
09
0808
PINNACLE3 SMARTARC
K
08
3414
RADIONICS XKNIFE HDRT SYSTEM
K
08
3264
RAYAUTOPLAN 1.0
K
08
2606
COMMISSIONING DATA MANAGEMENT SYSTEM (CDMS)
K
08
2642
ONCENTRA RT VIEWER 1.0
K
08
2221
RAYDOSE
K
08
2005
MODIFICATION TO HI-ART TREATMENT SYSTEM
K
08
1112
FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM
K
08
0888
MODEIFICATION TO IPLAN RT DOSE
K
08
0601
ERGO++ VERSION 1.7
K
08
1281
OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)
K
08
0929
ONCENTRA GYN
K
07
3020
ECLIPSE TREATMENT PLANNING SYSTEM
K
07
1760
MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM
K
07
1938
MONACO RTP SYSTEM
K
07
1873
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
K
06
3230
INTEGRA RADIONICS IMAGEFUSION 3
K
06
3482
CROSSPLAN / ACCUSOFT-XL V.4.04
K
06
2967
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K
06
2032
ACCUSOFT, ACCUSOFT XL
K
06
2514
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K
06
1893
INTEGRA RADIONICS XKNIFE RT 4
K
05
3584
IPLAN RT DOSE
K
06
1440
P.D
K
06
1097
COHERENCE DOSIMETRIST, MODEL 2.2
K
05
0296
ECLIPSE TREATMENT PLANNING SYSTEM
K
05
2325
CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
K
05
1941
CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM
K
05
1497
VITESSE 2.0
K
04
1971
WIMRT MODULE FOR ARTP PLANNING SYSTEM
K
04
2861
ODYSSEY
K
04
2739
HI-ART SYSTEM
K
04
2269
LEKSELL GAMMAPLAN 4C WITH MULTIVIEW
K
04
1997
RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE
K
04
1403
ECLIPSE WITH AAA
K
03
1088
TRIMED PLAN, VERSION 2.2
K
04
1719
ONCENTRA-VISIR
K
04
0474
ACCUSOFT
K
04
0688
STANDARD IMAGING E.IMRT CALCULATOR
K
03
1281
ERGO SRS
K
03
2456
PROWESS
K
03
2724
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K
03
0821
SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5
K
03
2345
CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY
K
03
2209
NOMOS CORVUS 5.0M
K
03
1349
OTP 1.2
K
02
2961
RTDOSEPLAN
K
02
2036
SIEMENS VIRTUAL SIMULATION (VSIM)
K
02
2741
SPOT PRO (220V), MODEL 131.099
K
02
2307
KONRAD, MODEL V.2.0
K
02
0027
FOCUS RADIATION TREATMENT PLANNING SYSTEM
K
02
2411
PRECISEPLAN 2.0
K
01
3644
ACQPLAN 5.0
K
02
0971
DCM 2.0
K
02
1268
ECLIPSE, HELIOS OPTION
K
01
2575
PREFERNCE IMRT TREATMENT PLANNING MODULE
K
01
3673
HI-ART SYSTEM
K
01
3535
EVTOOL MODEL # V. 1.0
K
01
3112
FOCAL SIM
K
01
3661
XPLAN 2.2 WITH THE BODY SYSTEM
K
00
2132
ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS
K
01
2017
VARISEED 7.0
K
01
0682
HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM
K
01
1246
DCM 1.0
K
01
0784
PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1
K
00
2237
P3IMRT TM
K
00
2509
NOVALIS (SHAPED BEAM SURGERY SYSTEM)
K
00
1295
PIPER
K
00
2147
FOCUS
K
99
3675
PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM
K
00
2312
PROTON VISION 7.0
K
00
2240
RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0
K
99
4413
BRAINSCAN
K
00
1700
XPLAN 2.1
K
99
3895
OPTIRAD
K
00
0922
PROTON VISION
K
99
3923
ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM
K
99
2303
SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0
K
99
2762
BRACHYVISION 6.0
K
99
2434
ITP, MODEL 1.0
K
99
3766
HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM
K
99
0475
TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5
K
99
2864
RENDER-PLAN 3-D
K
99
2753
CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM
K
99
1237
XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL
K
99
1815
EXPLORER 3D
K
98
4532
CADPLAN HELIOS OPTION 6.0
K
98
3343
PLATO BRACHYTHERAPHY, MODEL V. 14.0
K
98
2696
INTERPLANT
K
99
0071
IMAGEFUSION 2.0
K
98
2791
ROCS TPS
K
98
4196
MODIFICATION TO PROWESS PRO-SIM
K
98
1678
STRATA, MODEL V.O.95
K
98
2821
MMS THERPACPLUS B3DTUI MODEL NUMBER 6.7
K
97
4770
ACQPLAN
K
91
5691
FOCUS RTP
MWW
Accessory - Film Dosimetry System
NMP
Needle, Isotope, Reprocessed
NZT
Dosimeter, Ionizing Radiation, Implanted
OIN
Prostate Seeding Kit
ONL
Conformal Brachytherapy Source
OVB
Hydrogel Spacer
PCT
Prostate Immobilizer Rectal Balloon
RGC
X-Ray Field Indicator Light (Laser)
Subpart G—Miscellaneous Devices
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
RA
/
subpart-f—therapeutic-devices
/
MUJ
/
K190387
View Source
RayStation
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190387
510(k) Type
Traditional
Applicant
RaySearch Laboratories AB (publ)
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
6/19/2019
Days to Decision
120 days
Submission Type
Summary