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
4897–4920 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 25, 2014
Optima XR200amx, Optima XR220amx
K142383 · IZL
Ge Medical Systems, LLC
Radiology · 30d
Cleared Sep 25, 2014
PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION
K133603 · JAK
Philips Medical Systems
Radiology · 304d
Cleared Sep 19, 2014
CLEAR GUIDE ONE
K141806 · IYO
Clear Guide Medical
Radiology · 78d
Cleared Sep 19, 2014
SURGIMAP
K141669 · LLZ
Nemaris, Inc.
Radiology · 88d
Cleared Sep 19, 2014
VANTAGE ELAN
K141472 · LNH
Toshiba America Medical Systems, In.C
Radiology · 108d
Cleared Sep 18, 2014
Veenstra Instruments VDC-506 Dose Calibrator
K142325 · KPT
Comecer Netherlands B.V.
Radiology · 29d
Cleared Sep 18, 2014
MOBILEDIAGNOST WDR
K141895 · IZL
Sedecal., Sa.
Radiology · 66d
Cleared Sep 18, 2014
CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY
K141885 · IZL
Minxray, Inc.
Radiology · 69d
Cleared Sep 18, 2014
DENTAL IMAGING SOFTWARE
K141607 · LLZ
Trophy
Radiology · 94d
Cleared Sep 18, 2014
DISCOVERY IQ
K141477 · KPS
Ge Medical Systems, LLC
Radiology · 106d
Cleared Sep 18, 2014
CORTEX ID SUITE
K141074 · KPS
Ge Medical Systems, LLC
Radiology · 146d
Cleared Sep 18, 2014
EBM IDO VIEWER
K140399 · LLZ
Ebm Technologies USA, LLC
Radiology · 212d
Cleared Sep 17, 2014
EMPRINT PROCEDURE PLANNING APPLICATION
K142048 · LLZ
Covidien, LLC
Radiology · 51d
Cleared Sep 17, 2014
Lung Density Analysis
K141069 · JAK
Imbio, LLC
Radiology · 146d
Cleared Sep 15, 2014
STEREOS WORKSTATION
K141137 · LLZ
Eos Imaging
Radiology · 137d
Cleared Sep 15, 2014
SOMATOM SCOPE/SOMATOM SCOPE POWER
K140912 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 159d
Cleared Sep 12, 2014
MYLABGAMMA
K142077 · IYN
Esaote, S.P.A.
Radiology · 43d
Cleared Sep 12, 2014
MYLABSEVEN, MYLABALPHA
K142008 · IYN
Esaote, S.P.A.
Radiology · 51d
Cleared Sep 12, 2014
BIOGRAPH TRUE PET/CT FAMILY SOFTWARE
K141971 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 53d
Cleared Sep 12, 2014
DX-D IMAGING PACKAGE
K141602 · MQB
Agfa Healthcare N.V.
Radiology · 88d
Cleared Sep 09, 2014
SC2000 and ACUSON X300 Diagnostic Ultrasound Systems
K142395 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 13d
Cleared Sep 08, 2014
XIDF-AWS801, ANGIO WORKSTATION, V5.31
K141541 · JAA
Toshibamedical Systems Corporation
Radiology · 90d
Cleared Sep 05, 2014
ARTIS ZEE/ZEEGO SW VC21
K141574 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 85d
Cleared Sep 05, 2014
MOSAIQ ONCOLOGY INFORMATION SYSTEM
K141572 · IYE
Impac Medical Systems, Inc.
Radiology · 85d