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
5017–5040 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 13, 2014
ONCENTRA BRACHY
K132816 · MUJ
Nucletron B.V.
Radiology · 277d
Cleared Jun 13, 2014
CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION
K132524 · JAK
Philips Medical Systems
Radiology · 305d
Cleared Jun 12, 2014
DURADIAGNOST
K141381 · KPR
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 16d
Cleared Jun 11, 2014
MAMMI
K140996 · KPS
General Equipment For Medical Imaging...
Radiology · 55d
Cleared Jun 11, 2014
INTRA-OPERATIVE ULTRASOUND TRANSDUCER
K140854 · ITX
Hitachi Aloka Medical, Ltd.
Radiology · 69d
Cleared Jun 11, 2014
CELESTEION, PCA-9000A/2
K140651 · KPS
Toshibamedical Systems Corporation
Radiology · 90d
Cleared Jun 10, 2014
HEARTNAVIGATOR RELEASE 2.0
K140138 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 139d
Cleared Jun 06, 2014
DR 400
K141192 · MQB
Agfa Healthcare N.V.
Radiology · 29d
Cleared Jun 05, 2014
LOGIQ S7 EXPERT, LOGIQ S7 PRO
K141261 · IYN
Ge Healthcare
Radiology · 21d
Cleared Jun 05, 2014
MEDICAD CLASSIC
K140434 · LLZ
Hectec GmbH
Radiology · 105d
Cleared Jun 03, 2014
0180 INTUITION, 0072 PRECISION
K140683 · KPR
Arcoma AB
Radiology · 77d
Cleared Jun 02, 2014
CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND...
K140364 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 110d
Cleared Jun 02, 2014
BRIGHTMATTER PLANNING SOFTWARE
K140337 · LLZ
Synaptive Medical, Inc.
Radiology · 112d
Cleared May 30, 2014
TERASON USMART3300 ULTRASOUND SYSTEM
K140773 · IYN
Teratech Corp.
Radiology · 63d
Cleared May 30, 2014
ULTRASOUND SCANNER SYSTEM BK2300
K140428 · IYO
B-K Medical Aps
Radiology · 100d
Cleared May 30, 2014
X-MIND UNITY
K132378 · EHD
De Gotzen S.R.L.
Radiology · 303d
Cleared May 29, 2014
XGEO GF50
K140326 · KPR
Samsung Electronics Co., Ltd.
Radiology · 108d
Cleared May 28, 2014
XGEO GC80
K140334 · KPR
Samsung Electronics Co., Ltd.
Radiology · 107d
Cleared May 28, 2014
XGEO GU60A
K140332 · KPR
Samsung Electronics Co., Ltd.
Radiology · 107d
Cleared May 28, 2014
CLEARVIEWHD
K140139 · LLZ
Clearview Diagnostics, Inc.
Radiology · 126d
Cleared May 23, 2014
VIVID T8/VIVID T8 PRO
K141067 · IYN
Ge Healthcare
Radiology · 29d
Cleared May 23, 2014
APLIO ARTIDA, V3.2
K140729 · IYN
Toshiba America Medical Systems, In.C
Radiology · 60d
Cleared May 23, 2014
MEDWS SOFTWARE (VARIANTS MEDVIEW, MEDDIAG, MEDMAMMO)
K132684 · LLZ
Medecom Sarl
Radiology · 268d
Cleared May 19, 2014
MAXIO
K132108 · JAK
Perfint Healthcare Pvt, Ltd.
Radiology · 315d