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
4249–4272 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 29, 2016
Cianna Medical SAVI Scout Reflector and SAVI Scout System
K161507 · PDW
Cianna Medical, Inc.
Radiology · 58d
Cleared Jul 28, 2016
ACUSON NX2 Diagnostic Ultrasound Systems
K161787 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Jul 28, 2016
MAMMI
K161631 · KPS
General Equipment For Medical Imaging
Radiology · 45d
Cleared Jul 28, 2016
LVivo Software Application
K161382 · LLZ
Diacardio, Ltd.
Radiology · 71d
Cleared Jul 28, 2016
SIMPLANT Online Case Review and SIMPLANT Editor
K161118 · LLZ
Dentsply Sirona
Radiology · 99d
Cleared Jul 28, 2016
8ch Foot Ankle Coil
K160935 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 115d
Cleared Jul 22, 2016
Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4
K161009 · JAK
Toshibamedical Systems Corporation
Radiology · 102d
Cleared Jul 20, 2016
MultiScan G-Arm System
K160984 · OXO
Beijing East Whale Imaging Technology...
Radiology · 104d
Cleared Jul 19, 2016
6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System
K161359 · IYN
Esaote, S.P.A.
Radiology · 64d
Cleared Jul 15, 2016
Comfort Cover
K161920 · IZH
Precision Dynamics Corporation
Radiology · 2d
Cleared Jul 15, 2016
FDR Visionary Suite
K152294 · KPR
Shimadzu Corporation
Radiology · 337d
Cleared Jul 14, 2016
LEONI ORION System
K160518 · JAI
Leoni Cia Cable System
Radiology · 141d
Cleared Jul 13, 2016
TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System
K161525 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 41d
Cleared Jul 13, 2016
Multi Modality Viewer
K161419 · LLZ
Vital Images, Inc.
Radiology · 51d
Cleared Jul 13, 2016
PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory
K161163 · LHN
Hitachi , Ltd.
Radiology · 79d
Cleared Jul 11, 2016
syngo®.via protoNeo (Version VA10A)
K161685 · LLZ
Siemens Healthcare GmbH
Radiology · 24d
Cleared Jul 08, 2016
S-scan
K161238 · LNH
Esaote, S.P.A.
Radiology · 67d
Cleared Jul 07, 2016
Cydar EV
K160088 · OWB
Cydar , Ltd.
Radiology · 174d
Cleared Jul 06, 2016
SPEC Model M13
K161395 · KXK
Source Production and Equipment Co.,...
Radiology · 48d
Cleared Jul 06, 2016
RadPRO® Mobile 40kW
K161345 · IZL
Sedecal., Sa.
Radiology · 54d
Cleared Jul 06, 2016
GC85A
K160997 · KPR
Samsung Electronics Co., Ltd.
Radiology · 86d
Cleared Jun 30, 2016
RTHawk, HeartVista Cardiac Package
K153740 · LNH
Heartvista, Inc.
Radiology · 185d
Cleared Jun 29, 2016
Ablation Confirmation
K161285 · JAK
Neuwave Medical, Inc.
Radiology · 51d
Cleared Jun 29, 2016
ADMIRE
K153360 · JAK
Siemens Medi Cal Solutions, Inc.
Radiology · 222d