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
6097–6120 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 20, 2011
AXXENT RADIATION SHIELD - RIGID
K111299 · JAD
Xoft, an Icad Company
Radiology · 72d
Cleared Jul 20, 2011
COMMUNIFY PACS VIEWER
K110797 · LLZ
Flying Squirrel Storage, LLC
Radiology · 120d
Cleared Jul 20, 2011
OPTIMA CT660
K110227 · JAK
Ge Medical Systems, LLC
Radiology · 176d
Cleared Jul 19, 2011
MOBILEDIAGNOST WDR
K111725 · IZL
Sedecal., Sa.
Radiology · 29d
Cleared Jul 19, 2011
OPTIMA XR120
K111304 · IXL
Ge Medical Systems, LLC
Radiology · 71d
Cleared Jul 19, 2011
BEL-CAT
K101181 · OAS
Takara Belmont Corp.
Radiology · 448d
Cleared Jul 15, 2011
E-CUBE 9
K111864 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 15d
Cleared Jul 15, 2011
G-SCAN
K111803 · LNH
Esaote, S.P.A.
Radiology · 18d
Cleared Jul 15, 2011
VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM
K111706 · IYO
Volcano Corporation
Radiology · 28d
Cleared Jul 15, 2011
FALCON
K111416 · JOP
Viasonix , Ltd.
Radiology · 56d
Cleared Jul 13, 2011
SANTEVIEW
K111312 · MQB
Sehyun Co., Ltd.
Radiology · 64d
Cleared Jul 13, 2011
PANOURA 18S
K111231 · MUH
The Yoshida Dental Mfg. Co., Ltd.
Radiology · 72d
Cleared Jul 13, 2011
CARDIAC SCANNER AND PROCESSING SYSTEM
K110507 · KPS
Spectrum Dynamics (Israel) , Ltd.
Radiology · 141d
Cleared Jul 08, 2011
DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K111435 · IYO
Shenzhen Mindray Bio-Medical...
Radiology · 46d
Cleared Jul 05, 2011
SV DBS VRAIN ARRAY
K111259 · MOS
Midwest Rf, LLC
Radiology · 62d
Cleared Jul 01, 2011
ENDOSCOUT TRACKING SYSTEM
K111226 · LNH
Robin Medical, Inc.
Radiology · 60d
Cleared Jul 01, 2011
SIMPLANT 2011
K110300 · LLZ
Materialise Dental NV
Radiology · 149d
Cleared Jun 30, 2011
ACUSON
K111674 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Jun 30, 2011
CLIO/CLIOSOFT
K110886 · LLZ
Sota Precision Optics, Inc.
Radiology · 92d
Cleared Jun 30, 2011
SCANORA 3D
K110839 · OAS
Soredex Palodex Group OY
Radiology · 97d
Cleared Jun 30, 2011
EZONO 3000
K102813 · IYN
Life-Tech, Inc.
Radiology · 275d
Cleared Jun 30, 2011
PROVU (TM) DENTAL X-RAY SYSTEM
K102573 · EAP
Advanced Image Science, Inc.
Radiology · 294d
Cleared Jun 28, 2011
HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM
K111340 · LNH
Medtec, Inc.
Radiology · 47d
Cleared Jun 28, 2011
HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER
K110752 · ITX
Highland Instruments
Radiology · 102d