FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
4705–4728 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 11, 2015
XIDF-AWS801, Angio Workstation, v5.31
K142736 · OWB
Toshibamedical Systems Corporation
Radiology · 169d
Cleared Mar 11, 2015
DRX-EVOLUTION
K141837 · KPR
Carestream Health, Inc.
Radiology · 247d
Cleared Mar 10, 2015
Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio
K143753 · MUH
Rayence Co., Ltd.
Radiology · 69d
Cleared Mar 10, 2015
DR Systems Zero Download 3D Viewer (Z3D)
K143318 · LLZ
Dr Systems, Inc.
Radiology · 111d
Cleared Mar 10, 2015
Aquilion ONE Vision, v7.0
K142465 · JAK
Toshibamedical Systems Corporation
Radiology · 189d
Cleared Mar 10, 2015
Martinez Prostate Template Set
K142439 · JAQ
Nucletron B.V.
Radiology · 193d
Cleared Mar 10, 2015
PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC...
K141624 · JAQ
Varian Medical Systems, Inc.
Radiology · 266d
Cleared Mar 06, 2015
Sirius Starmobile tiara
K143537 · IZL
Hitachi Medical Systems America, Inc.
Radiology · 81d
Cleared Mar 06, 2015
3.0T GEM RT Open Array
K143389 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 100d
Cleared Mar 06, 2015
X-RAY TV SYSTEM SONIALVISION G4
K142341 · JAA
Shimadzu Corp.
Radiology · 197d
Cleared Mar 06, 2015
VIEWING CLIENT MOBILE
K141536 · LLZ
Axon Medical Technologies Corp.
Radiology · 269d
Cleared Mar 05, 2015
Vitrea, Version 7.0 Medical Image Processing Software
K150258 · LLZ
Vital Images, Inc.
Radiology · 30d
Cleared Mar 05, 2015
TraumaCad Mobile Release 1.0
K142923 · LLZ
Voyant Health, Ltd.
Radiology · 148d
Cleared Mar 04, 2015
ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System
K150249 · IYN
Zonare Medical Systems, Inc.
Radiology · 29d
Cleared Mar 04, 2015
Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic...
K150087 · IYN
Ge Vingmed Ultrasound AS
Radiology · 48d
Cleared Mar 04, 2015
iGuide 2.1
K143485 · IYE
Medical Intelligence Medizintechnik GmbH
Radiology · 86d
Cleared Mar 02, 2015
GE EchoPAC
K150085 · LLZ
Ge Vingmed Ultrasound AS
Radiology · 46d
Cleared Mar 02, 2015
TRILLIUM Oval MR System
K142734 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 160d
Cleared Feb 24, 2015
Syngo X-workplace SW VD10
K143319 · LLZ
Siemens Medi Cal Solutions, Inc.
Radiology · 97d
Cleared Feb 24, 2015
THD REVOLUTION
K141657 · JAF
Thd Spa
Radiology · 249d
Cleared Feb 20, 2015
Terason uSmart3300 Ultrasound System
K150148 · IYN
Teratech Corp.
Radiology · 28d
Cleared Feb 20, 2015
Volcano iFR Harvest Software (Offline)
K143122 · IYO
Volcano Corporation
Radiology · 112d
Cleared Feb 20, 2015
U50 Diagnostic Ultrasound System
K142511 · IYN
Edan Instruments, Inc.
Radiology · 165d
Cleared Feb 19, 2015
GM60A-32S & GM60A-40S
K150097 · IZL
Samsung Electronics Co., Ltd.
Radiology · 30d