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
3913–3936 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 01, 2017
NuVasive NuvaLine Mobile App
K162647 · LLZ
Nu Vasive, Incorporated
Radiology · 221d
Cleared Apr 28, 2017
syngo.CT View&GO
K170952 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Apr 28, 2017
Z-DOSE29
K170273 · JAK
Zetta Medical Technologies, LLC
Radiology · 88d
Cleared Apr 28, 2017
Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)
K161724 · IYE
Radiomed Corporation
Radiology · 310d
Cleared Apr 27, 2017
RadiForce MX315W
K170949 · PGY
Eizo Corporation
Radiology · 27d
Cleared Apr 27, 2017
RSM 2430C
K170930 · MUE
DRTECH Corporation
Radiology · 29d
Cleared Apr 26, 2017
AmCAD-UV
K170069 · LLZ
Amcad Biomed Corporation
Radiology · 107d
Cleared Apr 25, 2017
Cliniview
K162799 · LLZ
Palodex Group OY
Radiology · 202d
Cleared Apr 24, 2017
FDR AQRO (DR-XD 1000)
K170858 · IZL
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 33d
Cleared Apr 21, 2017
PercuNav Image Fusion and Interventional Navigation
K170716 · JAK
Philips Ultrasound, Inc.
Radiology · 43d
Cleared Apr 21, 2017
syngo.CT Cardiac Planning
K170221 · JAK
Siemens Healthcare GmbH
Radiology · 86d
Cleared Apr 20, 2017
DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound...
K163690 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 113d
Cleared Apr 20, 2017
HyperSense
K162722 · LNH
Ge Medical Systems, LLC
Radiology · 203d
Cleared Apr 13, 2017
Patient Positioning System
K170502 · JAI
Forte Automation Systems, Inc.
Radiology · 51d
Cleared Apr 13, 2017
Interson USB Ultrasound System
K163443 · IYN
Interson Corporation
Radiology · 126d
Cleared Apr 11, 2017
CyberKnife Treatment Delivery System
K170788 · IYE
Accuray Incorportaed
Radiology · 26d
Cleared Apr 11, 2017
Carestream Vue PACS
K170580 · LLZ
Carestream Health, Inc.
Radiology · 42d
Cleared Apr 11, 2017
LOGIQ S8
K170445 · IYN
Ge Healthcare
Radiology · 56d
Cleared Apr 10, 2017
Comfort EC710
K163192 · LNH
Alltech Medical Systems America, Inc.
Radiology · 146d
Cleared Apr 07, 2017
ORTHOPANTOMOGRAPH OP 3D
K170813 · OAS
Palodex Group OY
Radiology · 21d
Cleared Apr 07, 2017
Philips iCT CT System
K162838 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 178d
Cleared Apr 06, 2017
CORE M2 Vascular System
K170385 · IYO
Volcano Corporation
Radiology · 57d
Cleared Apr 06, 2017
Synapse 3D Perfusion Analysis
K162287 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 234d
Cleared Apr 05, 2017
Nio Color 3MP (MDNC-3421)
K170837 · PGY
Barco N.V.
Radiology · 15d