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
5713–5736 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 23, 2012
NIO 5MP
K121788 · LLZ
Barco N.V.
Radiology · 35d
Cleared Jul 20, 2012
Z6 DIAGNOSTIC ULTRASOUND SYSTEM
K122010 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 11d
Cleared Jul 20, 2012
CR 10-X DIGITIZER
K121948 · MQB
Agfa Healthcare N.V.
Radiology · 17d
Cleared Jul 20, 2012
VERSAVUE ENTERPRISE SUITE
K121517 · LLZ
Icad, Inc.
Radiology · 59d
Cleared Jul 19, 2012
CFR QUANT
K113754 · KPS
University of Texas Medical School AT...
Radiology · 211d
Cleared Jul 16, 2012
MAGNETOM SPECTRA
K121160 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 91d
Cleared Jul 16, 2012
3MP COLOR LCD MONITOR, RADIFORCE RX340
K113562 · LLZ
Eizo Nanao Corporation
Radiology · 228d
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