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
4177–4200 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 27, 2016
Interlocked Circular Small Field Collimators, Elekta Integrated
K161984 · IYE
Aktina Medical Corporation
Radiology · 70d
Cleared Sep 22, 2016
ArtPix Mobile EZ2GO
K162224 · KPR
Cmt Medical Technologies, Ltd.
Radiology · 45d
Cleared Sep 22, 2016
DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging...
K161368 · MQB
Agfa Healthcare N.V.
Radiology · 128d
Cleared Sep 21, 2016
Scenium
K162339 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Sep 21, 2016
CAAS MRV
K162112 · LLZ
Pie Medical Imaging BV
Radiology · 54d
Cleared Sep 21, 2016
Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0
K161843 · IYN
Toshibamedical Systems Corporation
Radiology · 78d
Cleared Sep 21, 2016
E-CUBE 11
K161439 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 120d
Cleared Sep 19, 2016
5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR
K162497 · PGY
Eizo Corporation
Radiology · 12d
Cleared Sep 19, 2016
PixelShine
K161625 · LLZ
Algomedica
Radiology · 98d
Cleared Sep 16, 2016
TRILLIUM Oval Head Coil 32
K162079 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 51d
Cleared Sep 16, 2016
JiveX
K162008 · LLZ
Visus Technology Transfer GmbH
Radiology · 58d
Cleared Sep 16, 2016
DoseCHECK
K161946 · IYE
Sun Nuclear Corporation
Radiology · 63d
Cleared Sep 14, 2016
CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System
K162329 · IYN
Philips Health Care
Radiology · 26d
Cleared Sep 14, 2016
dS FootAnkle I6CH 1.5T Coil
K162177 · MOS
Invivo Corporation
Radiology · 41d
Cleared Sep 14, 2016
EBit Series Diagnostic Ultrasound System
K162172 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 42d
Cleared Sep 09, 2016
ClearRead CT
K161201 · OEB
Riverain Technologies, LLC
Radiology · 134d
Cleared Sep 08, 2016
Symbia 6.5
K162337 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 17d
Cleared Sep 08, 2016
SonoSite iViz Ultrasound System
K162288 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 24d
Cleared Sep 08, 2016
PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector
K161966 · MQB
Perkinelmer, Inc.
Radiology · 52d
Cleared Sep 08, 2016
2MP Color LCD Monitor CCL214 (CL21214)
K161895 · PGY
Jvckenwood Corporation
Radiology · 59d
Cleared Sep 06, 2016
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound...
K162267 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 26d
Cleared Sep 06, 2016
ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System
K162243 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 27d
Cleared Sep 06, 2016
ACUSON SC2000 Diagnostic Ultrasound System
K162221 · IYN
Siemens Medical Solutions Inc....
Radiology · 29d
Cleared Sep 06, 2016
Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)
K161459 · MQB
Varian Medical Systems, X-Ray...
Radiology · 103d