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
5689–5712 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 12, 2012
RENAISSANCE
K120812 · HAW
Mazor Robotics , Ltd.
Radiology · 118d
Cleared Jul 12, 2012
MYRIAN 1.11
K113620 · LLZ
Intrasense
Radiology · 218d
Cleared Jul 11, 2012
LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM
K121838 · MQB
Liebel-Flarsheim
Radiology · 19d
Cleared Jul 11, 2012
MINICAT
K113421 · JAK
Xoran Technologies, Inc.
Radiology · 236d
Cleared Jul 10, 2012
V5MS TRANSDUCER
K121807 · ITX
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Jul 10, 2012
DIRECTPATH
K121449 · LLZ
Cybernet Systems Co., Ltd.
Radiology · 56d
Cleared Jul 10, 2012
VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K120263 · MUH
Genoray Co., Ltd.
Radiology · 162d
Cleared Jul 09, 2012
S-SCAN
K121650 · LNH
Esaote, S.P.A.
Radiology · 34d
Cleared Jul 09, 2012
THINKINGNET, THINKINGPACS/RIS - PROPRIETARY NAME FRO THINKINGNET,...
K120305 · LLZ
Thinking Systems Corp.
Radiology · 159d
Cleared Jul 05, 2012
SIMPLANT GO
K120733 · LLZ
Materialise Dental NV
Radiology · 118d
Cleared Jul 05, 2012
SYNAPSE 3D CARDIAC TOOLS
K120636 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 126d
Cleared Jul 05, 2012
CARDIOPACS
K120514 · LLZ
Lumedx
Radiology · 135d
Cleared Jul 02, 2012
ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY
K121448 · MUJ
Elekta Inc. D/B/A Nucletron Corporation
Radiology · 48d
Cleared Jun 29, 2012
EXACTRAC ROBOTICS NOVALIS ROBOTICS
K120520 · JAI
Brainlab AG
Radiology · 129d
Cleared Jun 27, 2012
ARTISTETM SOLUTION WITH SYS VCIO
K121295 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 58d
Cleared Jun 22, 2012
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND...
K121699 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Jun 22, 2012
ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND...
K121646 · IYN
Siemens Medical Solutions USA, Inc....
Radiology · 17d
Cleared Jun 22, 2012
APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM
K121577 · IYN
Toshiba Medical Systems Corporation,...
Radiology · 23d
Cleared Jun 22, 2012
SYNGO.MR NEUROLOGY
K121459 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 36d
Cleared Jun 22, 2012
CS 8100 CS 8100 ACCESS
K120975 · MUH
Trophy
Radiology · 81d
Cleared Jun 22, 2012
QUANTRA
K120472 · LLZ
Hologic, Inc.
Radiology · 127d
Cleared Jun 22, 2012
SHEATHES ULTRASOND GEL
K112827 · MUI
Sheathing Technologies, Inc.
Radiology · 268d
Cleared Jun 20, 2012
BODYFIX SYSTEM
K121530 · IYE
Medical Intelligence Medizintechnik GmbH
Radiology · 27d
Cleared Jun 20, 2012
QFIX RADIOTHERAPY CHAIR
K120916 · JAI
Wfr/Aquaplast Corp.
Radiology · 85d