FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
3193–3216 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 05, 2019
Imagio Ultrasound Imaging System
K182628 · IYN
Seno Medical Instruments, Inc.
Radiology · 162d
Cleared Mar 01, 2019
ODI HD Dental Sensor
K190234 · MUH
Cnd Global Technologies, Inc.
Radiology · 23d
Cleared Mar 01, 2019
ClearON Mobile
K183478 · LLZ
Rayence Co., Ltd.
Radiology · 74d
Cleared Feb 27, 2019
FibermarX Radiopaque Tissue Marker
K190155 · IYE
Viscus Biologics, LLC
Radiology · 28d
Cleared Feb 27, 2019
EzDent-i / E2 / Prora View
K190087 · LLZ
Ewoosoft Co., Ltd.
Radiology · 41d
Cleared Feb 27, 2019
uPMR 790
K183014 · OUO
Shanghai United Imaging Healthcare...
Radiology · 119d
Cleared Feb 26, 2019
GrayDuck Stent
K183374 · IYE
Poll Medical, LLC
Radiology · 82d
Cleared Feb 25, 2019
Zap-X Radiosurgery System
K183698 · IYE
Zap Surgical Systems
Radiology · 56d
Cleared Feb 22, 2019
EMMA 1.5T MRI System
K183621 · LNH
Time Medical Limited
Radiology · 58d
Cleared Feb 22, 2019
IRIS 1.0 System
K182643 · LLZ
Intuitive Surgical
Radiology · 151d
Cleared Feb 21, 2019
Sensus Healthcare TVM Balloon Applicator
K190255 · JAD
Sensus Healthcare, Inc.
Radiology · 14d
Cleared Feb 21, 2019
Sensus TPS Workstation
K182665 · MUJ
Sensus Healthcare, Inc.
Radiology · 149d
Cleared Feb 21, 2019
Sensus IORT System
K182641 · JAD
Sensus Healthcare, Inc.
Radiology · 150d
Cleared Feb 20, 2019
MRIdian Linac System
K181989 · IYE
Viewray, Incorporated
Radiology · 209d
Cleared Feb 15, 2019
MAGNETOM Aera
K190138 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 17d
Cleared Feb 15, 2019
MAGNETOM Terra
K183222 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 87d
Cleared Feb 15, 2019
RS85 Diagnostic Ultrasound System
K182932 · IYN
Samsung Medison Co., Ltd.
Radiology · 116d
Cleared Feb 15, 2019
PhantomMSK
K182332 · LLZ
OrthoGrid Systems, Inc.
Radiology · 171d
Cleared Feb 14, 2019
MAGNETOM Amira, MAGNETOM Sempra
K183221 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 86d
Cleared Feb 14, 2019
Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
K183063 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 101d
Cleared Feb 14, 2019
MyoStrain 5.1
K182756 · LNH
Myocardial Solutions
Radiology · 139d
Cleared Feb 13, 2019
SnapShot Freeze 2
K183161 · JAK
Ge Medical Systems, LLC
Radiology · 90d
Cleared Feb 12, 2019
Cruxcan (CRX-1000)
K183637 · MUH
Cruxell Corp.
Radiology · 48d
Cleared Feb 08, 2019
Carestream DRX-1 System with DRX Plus 2530 Detectors
K183245 · MQB
Carestream Health, Inc.
Radiology · 79d