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
4153–4176 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 17, 2016
Infinix, INFX-8000V, V6.35
K162614 · OWB
Toshibamedical Systems Corporation
Radiology · 28d
Cleared Oct 17, 2016
bk2300
K161960 · IYN
Bk Medical Aps
Radiology · 91d
Cleared Oct 14, 2016
BSD3543 Digital Flat Panel X-ray Detector
K162487 · MQB
Bontech, Inc.
Radiology · 37d
Cleared Oct 14, 2016
MyLabSix CrystaLine
K162290 · IYN
Esaote, S.P.A.
Radiology · 60d
Cleared Oct 14, 2016
MedDream
K162011 · LLZ
Softneta Uab
Radiology · 85d
Cleared Oct 14, 2016
NovaPACS
K160371 · LLZ
Novarad Corporation
Radiology · 247d
Cleared Oct 14, 2016
ANYVIEW-500R Fluoroscopic Mobile X-Ray System
K160279 · OWB
Ecotron Co., Ltd.
Radiology · 255d
Cleared Oct 06, 2016
1717WCC / 1717WGC
K162519 · MQB
Rayence Co., Ltd.
Radiology · 27d
Cleared Oct 06, 2016
1012WCC, 1012WGC
K162518 · MQB
Rayence Co., Ltd.
Radiology · 27d
Cleared Oct 06, 2016
Ziehm Solo FD
K161976 · OWB
Ziehm Imaging GmbH
Radiology · 80d
Cleared Oct 06, 2016
CuattroDR
K161937 · KPR
Cuattro, LLC
Radiology · 84d
Cleared Oct 06, 2016
iSR'obot MRI-US Fusion
K161109 · LLZ
Biobot Surgical Pte., Ltd.
Radiology · 169d
Cleared Oct 05, 2016
Dentiq3D
K160666 · LLZ
3D Industrial Imaging Co., Ltd.
Radiology · 210d
Cleared Oct 03, 2016
Lumify Ultrasound System
K162549 · IYN
Philips Health Care
Radiology · 20d
Cleared Oct 03, 2016
SKR 3000
K162504 · MQB
Konica Minolta, Inc.
Radiology · 26d
Cleared Oct 03, 2016
Voluson E6, Voluson E8, Voluson E10
K162269 · IYN
Ge Healthcare
Radiology · 52d
Cleared Oct 03, 2016
PreXion3D Excelsior
K161881 · OAS
Prexion Corporation
Radiology · 87d
Cleared Oct 03, 2016
kneeEOS
K161828 · LLZ
Onefit Medical
Radiology · 90d
Cleared Oct 03, 2016
RS80A Diagnostic Ultrasound System
K153539 · IYN
Samsung Medison Co., Ltd.
Radiology · 298d
Cleared Oct 02, 2016
Esophagus Bougie Set
K161576 · JAQ
Varian Medical Systems, Inc.
Radiology · 117d
Cleared Sep 30, 2016
8MP Color LCD Monitor (C81W+)
K162527 · PGY
Shenzhen Beacon Display Technology...
Radiology · 21d
Cleared Sep 30, 2016
Xario 100 Diagnostic Ultrasound System, V5.0
K162187 · IYN
Toshibamedical Systems Corporation
Radiology · 57d
Cleared Sep 30, 2016
DENTRIa series
K160140 · OAS
Hdx Will Corp.
Radiology · 253d
Cleared Sep 28, 2016
Acuson Freestyle Ultrasound System
K162417 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 29d