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
3961–3984 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Apr 05, 2017
Anzai Respiratory Gating System
K170719 · LHN
Anzai Medical Co., Ltd.
Radiology · 27d
Cleared Apr 05, 2017
IQon Spectral CT
K163711 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 96d
Cleared Apr 05, 2017
Segment CMR
K163076 · LLZ
Medviso AB
Radiology · 153d
Cleared Apr 05, 2017
UltraScan 650
K161919 · MUA
Cyberlogic, Inc.
Radiology · 266d
Cleared Apr 05, 2017
LIFESYS PACS
K161341 · LLZ
Lifetrack Medical Systems, Inc.
Radiology · 327d
Cleared Apr 04, 2017
MX50N(MX50YQS)
K170781 · PGY
Wide Corporation
Radiology · 20d
Cleared Apr 04, 2017
System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight
K170731 · MUH
VATECH Co., Ltd.
Radiology · 25d
Cleared Apr 04, 2017
Acuson SC2000 Diagnostic Ultrasound System
K170315 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 62d
Cleared Mar 31, 2017
CX50N(CX50YQS)
K170783 · PGY
Wide Corporation
Radiology · 16d
Cleared Mar 31, 2017
Move Forward 3D Motion Simulation Service
K162559 · LLZ
Biomet, Inc.
Radiology · 198d
Cleared Mar 28, 2017
HS50 / HS60 Diagnostic Ultrasound System
K170493 · IYN
Samsung Medison Co., Ltd.
Radiology · 39d
Cleared Mar 28, 2017
Nio Color 5.8MP (MDNC-6121)
K170476 · PGY
Barco N.V.
Radiology · 40d
Cleared Mar 24, 2017
Scan&GO
K163297 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 122d
Cleared Mar 24, 2017
INFINITT ULite
K163290 · LLZ
Infinitt Co., Ltd.
Radiology · 122d
Cleared Mar 24, 2017
Mould Applicator Set
K162615 · JAQ
Varian Medical Systems, Inc.
Radiology · 186d
Cleared Mar 23, 2017
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System
K170277 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 52d
Cleared Mar 21, 2017
360KS Implant Positioning System
K163405 · LLZ
Kico Knee Innovation Company Pty Limited
Radiology · 106d