FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
3937–3960 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
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