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
4321–4344 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 02, 2016
MX50T(MX50TQS)
K160354 · PGY
Wide Corporation
Radiology · 84d
Cleared Apr 29, 2016
Mobius3D
K153014 · IYE
Mobius Medical Systems, LP
Radiology · 197d
Cleared Apr 29, 2016
TBS iNsight
K152299 · KGI
Medimaps Group SA
Radiology · 260d
Cleared Apr 26, 2016
Voluson P6, Voluson P8
K160162 · IYN
Ge Healthcare
Radiology · 90d
Cleared Apr 25, 2016
MIM-Thin Client (mobile)
K151913 · LLZ
Mim Software, Inc.
Radiology · 287d
Cleared Apr 22, 2016
sterEOS Workstation
K160914 · LLZ
Eos Imaging, Inc.
Radiology · 21d
Cleared Apr 22, 2016
Anzai Respiratory Gating System
K160432 · LHN
Anzai Medical Co., Ltd.
Radiology · 66d
Cleared Apr 22, 2016
MX50N(MX50YQS)
K160353 · PGY
Wide Corporation
Radiology · 74d
Cleared Apr 21, 2016
PROBEAT-V and accessories
K153614 · LHN
Hitachi, Ltd., Health Care Company
Radiology · 126d
Cleared Apr 20, 2016
Leksell Gamma Knife Icon
K160440 · IWB
Elekta Instrument AB
Radiology · 63d
Cleared Apr 19, 2016
Fujifilm Sonosite Vevo MD Imaging System
K160674 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 40d
Cleared Apr 19, 2016
AIRO Computed Tomography (CT) X-ray System
K160126 · JAK
Mobius Imaging
Radiology · 90d
Cleared Apr 15, 2016
Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder...
K160792 · IYO
The Prometheus Group
Radiology · 23d
Cleared Apr 15, 2016
RIOScan (RPS500)
K160788 · MUH
Ray Co., Ltd.
Radiology · 24d
Cleared Apr 15, 2016
MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit
K153343 · LNH
Siemens Medi Cal Solutions, Inc.
Radiology · 148d
Cleared Apr 14, 2016
CX30N (CX30PQX)
K160348 · PGY
Wide Corporation
Radiology · 66d
Cleared Apr 14, 2016
MX30N(MX30TQS)
K160346 · PGY
Wide Corporation
Radiology · 66d
Cleared Apr 13, 2016
Varian Sterilization Boxes
K160021 · JAQ
Varian Medical Systems, Inc.
Radiology · 99d
Cleared Apr 13, 2016
DICOM Viewer
K153653 · LLZ
Brainlab AG
Radiology · 114d
Cleared Apr 12, 2016
EndoSize
K160376 · LLZ
Therenva Sas
Radiology · 62d
Cleared Apr 08, 2016
Xmaru View V1 and Xmaru PACS, Medical Image Processing Software
K160579 · LLZ
Rayence Co., Ltd.
Radiology · 38d
Cleared Apr 08, 2016
spineEOS
K160407 · LLZ
Onefit Medical
Radiology · 52d
Cleared Apr 08, 2016
RayStation
K160093 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 80d
Cleared Apr 08, 2016
Bladder Scanner
K153581 · IYO
Caresono Technology Co., Ltd.
Radiology · 115d