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
3985–4008 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 21, 2017
SOMATOM go.Up, SOMATOM go.Now
K163296 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 119d
Cleared Mar 21, 2017
SmartGrid
K163157 · MQB
Carestream Health
Radiology · 131d
Cleared Mar 20, 2017
Bel-Cypher Pro
K163175 · MUH
Takara Belmont Corporation
Radiology · 126d
Cleared Mar 17, 2017
Discovery MR750 3.0T
K163331 · LNH
Ge Medical Systems, LLC
Radiology · 109d
Cleared Mar 17, 2017
Exam Vue PACS
K162868 · LLZ
Jpi Healthcare Solutions, Inc.
Radiology · 155d
Cleared Mar 16, 2017
FDX Console (DR-ID300CL) Software
K170451 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 29d
Cleared Mar 16, 2017
6200 Ultrasound System and 6250 Ultrasound System
K163082 · IYN
Esaote, S.P.A.
Radiology · 133d
Cleared Mar 15, 2017
LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source
K163572 · KXK
Lv Liberty Vision Corp.
Radiology · 86d
Cleared Mar 10, 2017
Interstitial Needles
K160815 · JAQ
Varian Medical Systems, Inc.
Radiology · 351d
Cleared Mar 09, 2017
ARTIS pheno
K163286 · OWB
Siemens Medical Solution USA, Inc.
Radiology · 107d
Cleared Mar 09, 2017
JAZZ SOLO Sensor
K163224 · MUH
Jazz Imaging, LLC
Radiology · 113d
Cleared Mar 08, 2017
CRC-77tHR
K162394 · KPT
Capintec, Inc.
Radiology · 194d
Cleared Mar 03, 2017
True 3D Viewer Software
K170167 · LLZ
Echopixel, Inc.
Radiology · 43d
Cleared Mar 03, 2017
TheraView TBI
K170058 · IYE
Cablon Medical B.V.
Radiology · 56d
Cleared Mar 03, 2017
HITACHI Supria Whole-body X-ray CT System Phase 3
K163528 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 77d
Cleared Mar 03, 2017
DigiX FDX
K162529 · KPR
Allengers Medical Systems Limited
Radiology · 175d
Cleared Mar 02, 2017
RayStation 6
K170355 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 24d
Cleared Mar 01, 2017
DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS
K170332 · MQB
Canon, Inc.
Radiology · 27d
Cleared Mar 01, 2017
syngo. CT Neuro Perfusion
K163284 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 99d
Cleared Feb 28, 2017
Apex Dental Sensors
K163282 · MUH
Masterlink, LLC
Radiology · 99d
Cleared Feb 28, 2017
Biograph mMR with syngo MR E11P system software
K163234 · OUO
Siemens Medical Solutions USA, Inc.
Radiology · 103d
Cleared Feb 28, 2017
Surface Applicator Set
K162018 · JAQ
Varian Medical Systems, Inc.
Radiology · 229d
Cleared Feb 24, 2017
The ViewRay (MRIdian) Linac System
K162393 · IYE
Viewray, Incorporated
Radiology · 182d
Cleared Feb 24, 2017
HF 718BD X-Ray System
K160857 · KPR
Arquilla, Inc. Dba X-Cel X-Ray...
Radiology · 332d