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
3937–3960 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 09, 2017
Ablation Confirmation
K171022 · JAK
Neuwave Medical, Inc.
Radiology · 34d
Cleared May 08, 2017
Will3D
K170180 · LLZ
Hdx Will Corp.
Radiology · 109d
Cleared May 05, 2017
In Reach
K170789 · JAK
Curvebeam, LLC
Radiology · 50d
Cleared May 04, 2017
Nucleus Image Management System
K171130 · LLZ
Nucleushealth, LLC
Radiology · 17d
Cleared May 01, 2017
Televere Digital Imaging System
K170975 · MQB
Televere Systems
Radiology · 28d
Cleared May 01, 2017
ScanX Intraoral View
K170733 · MUH
Duerr Dental AG
Radiology · 52d
Cleared May 01, 2017
NaviSuite SSI Edition
K163119 · LLZ
Medcom GmbH
Radiology · 174d
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