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
3769–3792 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 06, 2017
Edge Air Digital Flat Panel X-ray Detector
K172681 · MQB
Osko, Inc.
Radiology · 30d
Cleared Oct 06, 2017
Ingenuity TF
K172406 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 58d
Cleared Oct 06, 2017
Aquilion Prime SP, TSX-303B/1, v8.4
K172188 · JAK
Toshiba Medical Systems Coroporation
Radiology · 78d
Cleared Oct 05, 2017
Vitrea Advanced Visualization, Version 7.6
K172855 · LLZ
Vital Images, Inc.
Radiology · 15d
Cleared Oct 05, 2017
SyncVision System
K172574 · OWB
Volcano Corporation
Radiology · 38d
Cleared Oct 05, 2017
LinkQuest Diagnostic Ultrasound System model SQ860
K172059 · IYN
Linkquest, Inc.
Radiology · 90d
Cleared Oct 05, 2017
Aquarius 8600 1417WC
K171175 · MQB
Imaging Dynamics Company , Ltd.
Radiology · 167d
Cleared Oct 04, 2017
Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound...
K172607 · IYN
Philips Health Care
Radiology · 35d
Cleared Sep 29, 2017
U2 Diagnostic Ultrasound System
K172380 · IYN
Edan Instruments, Inc.
Radiology · 53d
Cleared Sep 29, 2017
Voluson E6, Voluson E8, Voluson E10
K172342 · IYN
Ge Healthcare
Radiology · 58d
Cleared Sep 29, 2017
Photoelectric Therapy System
K172080 · JAD
Xstrahl, Ltd.
Radiology · 81d
Cleared Sep 29, 2017
ASPIRE Bellus II
K171463 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 134d
Cleared Sep 29, 2017
BR-FHUS Navigation 1.0
K171309 · IYO
Taihao Medical, Inc.
Radiology · 149d
Cleared Sep 26, 2017
CareView 1800Cw X-ray Flat Panel Detectors
K172581 · MQB
Careray Digital Medical System Co., Ltd.
Radiology · 29d
Cleared Sep 26, 2017
Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine...
K170816 · LLZ
Brainlab AG
Radiology · 190d
Cleared Sep 22, 2017
Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing...
K171303 · KPS
University of Texas Medical School AT...
Radiology · 142d
Cleared Sep 21, 2017
S60 Series Digital Color Doppler Ultrasound System
K172082 · IYN
Sonoscape Medical Corp.
Radiology · 73d
Cleared Sep 21, 2017
ZS3 Ultrasound System, z.one pro Ultrasound System
K171891 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 87d
Cleared Sep 21, 2017
EndoNaut
K171829 · OWB
Therenva Sas
Radiology · 93d
Cleared Sep 21, 2017
Zap-X Radiosurgery System
K171804 · IYE
Zap Surgical Systems
Radiology · 94d
Cleared Sep 15, 2017
BladderScan Prime PLUS System
K172356 · IYO
Verathon Incorporated
Radiology · 43d
Cleared Sep 14, 2017
3D Echo
K172513 · LLZ
Jointvue, LLC
Radiology · 24d
Cleared Sep 14, 2017
Clarius Ultrasound System
K172385 · IYN
Clarius Mobile Health Corp.
Radiology · 37d
Cleared Sep 13, 2017
FibroScan 430 Mini+
K172142 · IYO
Echosens
Radiology · 58d