Atlas FDA

Radiology

14,649 FDA 510(k) clearances · Medical specialty

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
syngo Application Software (K163285)Siemens Medical Solution USA, Inc.2017-02-14
SIS Software (K162830)Surgical Information Sciences, Inc.2017-02-14
Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set (K160610)Kobold, LLC2017-02-13
LOGIQ P9 and LOGIQ P7 (K163596)GE Healthcare2017-02-10
syngo.CT Extended Functionality (K163341)Siemens Medical Solutions USA, Inc.2017-02-09
Pinnacle Radiation Therapy Planning System (K170086)Philips Medical Systems (Cleveland), Inc.2017-02-09
syngo. CT Single Source Dual Energy (twin beam) (K163289)Siemens Medical Solutions USA, Inc., Ultrasound DI2017-02-09
pixium 4343RCE (K170113)Philips Medical Systems Dmc GmbH2017-02-09
VIVIX-S 1417N (K163703)Vieworks Co., Ltd.2017-02-08
OptosAdvance 4.0 Software (K162039)Optos Plc.2017-02-08
syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology (K163294)Siemens Medical Solutions USA, Inc.2017-02-06
UC-CARE NaviGo Workstation (K160934)UC-CARE , Ltd.2017-02-06
Aquilion Lightning, TSX-036A/1, V8.4 (K170019)Toshibamedical Systems Corporation2017-02-02
Philips CombiDiagnost R90 (K163210)Philips Medical Systems Dmc GmbH2017-01-31
NobelClinician, DTX Studio implant (K163122)Nobel Biocare AB2017-01-31
Acclarix LX8 Diagnostic Ultrasound System (K162055)Edan Instruments, Inc.2017-01-31
Advanced Gynecological Applicator (K161688)Nucletron B.V.2017-01-27
EBM iDO Viewer 1.2.1 (K162285)Ebm Technologies Incorporated2017-01-27
MAGNETOM Sempra with syngo MR E11S (K163211)Siemens Medical Solutions USA, Inc.2017-01-27
nordicBrainEx (K163324)Nordicneurolab AS2017-01-27
CSX-30 Flat Panel Detector (K162909)Canon, Inc. – Medical Equipment Group2017-01-27
MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software (K163312)Siemens Medical Solutions USA, Inc.2017-01-27
Allura Xper R9 (K163715)Philips Medical Systems Nederland B.V.2017-01-26
FastStroke (K163281)Gef Medical Systems Scs2017-01-26
Multi Modality Viewer (K163574)Vital Images, Inc.2017-01-26
TrueBeam-TrueBeam STx-Edge (K162472)Varian Medical Systems, Inc.2017-01-19
Breast BI 7 MR Coil Mammavention 3T (K162651)Moras Mri Products GmbH2017-01-18
EzDent-i; E2; ProraView (K163533)Ewoosoft Co., Ltd.2017-01-12
48CH Head Coil (K163205)Ge Healthcare Coils (Usa Instruments, Inc.)2017-01-12
ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems (K163635)Siemens Medical Solutions USA, Inc. Ultrasound Group2017-01-12
EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System (K163120)Philips Ultrasound, Inc.2017-01-10
Mammomat Fusion with Stereotactic Biopsy (K163252)Siemens Medical Solutions USA, Inc.2017-01-10
Symbia Intevo Bold (K162483)Siemens Medical Solutions USA, Inc.2017-01-09
Bindex BI-2 (K161971)Bone Index Finland , Ltd.2017-01-09
D2P (K161841)3D Systems, Inc.2017-01-09
Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 (K162931)Philips Medical Systems Nederland B.V.2017-01-06
Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116)Philips Medical Systems Nederland B.V.2017-01-06
Quantib Brain 1.2 (K163013)Quantib B.V.2017-01-06
8ch Knee-Foot SPEEDER (K162946)Quality Electrodynamics, LLC2017-01-06
Arterys Cardio DL (K163253)Arterys, Inc.2017-01-05
ACUSON P500 Ultrasound System (K163396)Siemens Medical Solutions USA, Inc.2017-01-04
CephSimulation (K161270)Anatomage, Inc.2017-01-04
B6 (K163429)Beijing East Whale Imaging Technology Co., Ltd.2017-01-04
DigitalDiagnost C50 (K163410)Philips Healthcare (Suzhou) Co., Ltd.2017-01-04
X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System (K163427)Sonoscape Medical Corp.2017-01-03
syngo.via MI Workflows (K163421)Siemens Medical Solutions USA, Inc.2017-01-03
MultiBand SENSE (K162940)Philips Medical Systems Nederland B.V.2016-12-30
ClearView cCAD (K161959)Clearview Diagnostics, Inc.2016-12-28
Ez3D-i / E3 (K163539)Ewoosoft Co., Ltd.2016-12-23
EVS 4343, EVS 4343G (K162555)DRTECH Corporation2016-12-21
INNOLUX RIC (K162344)Innolux Corporation2016-12-20
Multi-Modality Tumor Tracking (MMTT) application (K162955)Philips Medical Systems Nederland B.V.2016-12-19
Revolution CT (K163213)Ge Medical Systems, LLC2016-12-16
Somatom Confidence ® RT Pro (K162302)Siemens Medical Solutions USA, Inc.2016-12-16
6MP Color LCD Monitor, RadiForce RX660, RX660-AR (K163335)Eizo Corporation2016-12-15
Zia (K160852)Zetta Medical Technologies, LLC2016-12-15
SMD-Sr90-DA Radionuclide Brachytherapy Source (K163206)Salutaris Medical Devices, Inc.2016-12-15
ARIETTA Prologue Diagnostic Ultrasound system and Transducers (K162902)Hitachi , Ltd.2016-12-15
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System (K162845)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2016-12-15
INTRABEAM 600 (K162568)Carl Zeiss Meditec, AG2016-12-15
Carestream DRX-Evolution (K163203)Carestream Health, Inc.2016-12-13
Varian High Energy Linear Accelerator (K162476)Varian Medical Systems, Inc.2016-12-12
UC-5000 Mobile X-Ray (K163063)Source-Ray, Inc.2016-12-12
HYPERION X5 (K161900)Cefla S.C.2016-12-09
16ch T/R Hand Wrist Coil (K162623)Quality Electrodynamics, LLC2016-12-09
ProNova SC360 Proton Therapy System (K162246)Pronova Solutions, LLC2016-12-08
CAAS MR 4D Flow (K162376)Pie Medical Imaging BV2016-12-08
Wireless Digital Flat Panel Detector (K161730)Iray Technology (Shanghai) , Ltd.2016-12-08
ImagingRing System (K161400)Medphoton GmbH2016-12-08
GC70 (K163115)Samsung Electronics Co., Ltd.2016-12-07
CT CoPilot (K161322)Zepmed, LLC2016-12-07
DENSEEMAMMO v1.0 (K152009)Statlife2016-12-05
MEDSYNAPSE Zero Footprint Viewer (K163158)Medsynaptic Private, Ltd.2016-12-02
FS-500DDR Medical Radiographic X-Ray System (K152813)Orich Medical Equipment (Tianjin) Co., Ltd.2016-12-02
ExactVu High Resolution Micro-Ultrasound System (K162972)Exact Imaging2016-12-02
Allura Xper FD series and Allura Xper OR Table series (K162859)Philips Medical Systems Nederland B.V.2016-12-02
EVS 3643, EVS 3643G (K162552)DRTECH Corporation2016-12-02
GE Lunar DXA Bone Densitometers with enCORE version 17 (K161682)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016-12-02
ClearCheck (K162468)Radformation2016-12-01
CareView 750Cw/750C X-ray Flat Panel Detectors (K163019)Careray Digital Medical System Co., Ltd.2016-12-01
TxRx Knee 15 Flare MR Coil 1.5T (K162966)Quality Electrodynamics, LLC2016-11-30
Clarius Ultrasound System (K163138)Clarius Mobile Health Corp.2016-11-30
LuminScan (TM) Imaging System (K162466)Micro-Tech (Nanjing) Co., Ltd.2016-11-29
TxRx Knee 15 Flare MR Coil 3.0T (K163066)Quality Electrodynamics, LLC2016-11-29
Vantage Galan 3T, MRT-3020, V4.0 (K162183)Toshibamedical Systems Corporation2016-11-25
Allura Xper R9 (K162148)Philips Medical Systems Nethrlands BV2016-11-23
Multix Fusion Max (K162971)Siemens Medical Solutions USA, Inc.2016-11-22
Raycast MammoRx Carbon Fibre Breast Board (K162355)Orfit Industries NV2016-11-22
ViewPoint 6 (K162743)GE Medical Systems Ultrasound and Primary Care Diagnostics2016-11-22
MAGNETOM Avantofit, MAGNETOM Skyrafit (K162102)Siemens Medi Cal Solutions, Inc.2016-11-22
Discovery NM 750b Bopsy (K160933)GE Healthcare2016-11-18
HyperBand (K162403)Ge Medical Systems, LLC2016-11-18
MAGNETOM ESSENZA (K161795)Siemens Medical Solutions USA, Inc.2016-11-18
Dosimetry Check Version 5 Release 1 (K162577)Math Resolutions, LLC2016-11-18
Heyman Packing Applicator Set (K160045)Varian Medical Systems, Inc.2016-11-17
LOGIQ E9, LOGIQ E9 XDClear 2.0 (K163077)GE Medical Systems Ultrasound and Primary Care Diagnostics2016-11-17
ALOKA LISENDO 880 (K162583)Hitachi , Ltd.2016-11-17
Aixplorer (K161999)Supersonic Imagine2016-11-16
syngo Application Software (K162541)Siemens Medical Solutions USA, Inc.2016-11-16
Xperius Ultrasound System (K163020)Philips Health Care2016-11-16
← Previous Next →

Track Radiology automatically

Every clearance here is in the API, with alerts when new ones post.