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
5689–5712 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 15, 2012
EXINI
K122205 · LLZ
Exini Diagnostics AB
Radiology · 21d
Cleared Aug 14, 2012
EXACTRAC X-RAY X-RAY
K120789 · IYE
Brainlab AG
Radiology · 152d
Cleared Aug 13, 2012
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
K120446 · FDS
Fujinon, Inc.
Radiology · 181d
Cleared Aug 10, 2012
IMRIS ONCOLOGY PACKAGE
K121997 · LNH
Imris, Inc.
Radiology · 32d
Cleared Aug 10, 2012
MULTIX FUSION
K121513 · KPR
Siemens Medical Solution
Radiology · 81d
Cleared Aug 10, 2012
BIOPSY DIGIT S BIOPSY SL
K113607 · IZH
Giotto USA, LLC
Radiology · 248d
Cleared Aug 10, 2012
ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT
K113210 · KXK
Isoaid, LLC
Radiology · 283d
Cleared Aug 06, 2012
G-SCAN BRIO
K122006 · LNH
Esaote, S.P.A.
Radiology · 28d
Cleared Aug 03, 2012
8MP COLOR LCD MONITOR, REDIFORCE RX840
K120451 · LLZ
Eizo Nanao Corporation
Radiology · 171d
Cleared Aug 03, 2012
IDENTIFY
K112692 · IYE
Humediq GmbH
Radiology · 323d
Cleared Aug 02, 2012
SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS
K121867 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 37d
Cleared Aug 02, 2012
DRAGON LW
K121410 · IZL
Sedecal., Sa.
Radiology · 83d
Cleared Aug 02, 2012
BT-200V VASCULAR DOPPLER
K121267 · HGM
Bistos Co., Ltd.
Radiology · 98d
Cleared Aug 02, 2012
MICROSOFT AMALGA UIS IMAGE PROCESSING MODULE
K120734 · LLZ
Microsoft Corp.
Radiology · 146d
Cleared Jul 30, 2012
DYNAPBV BODY SOFTWARE
K121292 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 91d
Cleared Jul 30, 2012
SENTINEL
K120668 · IYE
C-Rad Positioning AB
Radiology · 147d
Cleared Jul 26, 2012
E-CUBE INNO
K121937 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 24d
Cleared Jul 26, 2012
E-CUBE 15
K121888 · IYO
Alpinion Medical Systems Co., Ltd.
Radiology · 28d
Cleared Jul 26, 2012
AQUILION RXL
K121553 · JAK
Toshibamedical Systems Corporation
Radiology · 62d
Cleared Jul 26, 2012
MOBILE C-ARM
K121303 · OXO
Canon Inc. -Medical Equipment Group
Radiology · 86d
Cleared Jul 26, 2012
CS-SERIES-FP WITH 3030+OPTION
K121293 · JAA
Omega Medical Imaging, LLC
Radiology · 87d
Cleared Jul 26, 2012
NERVEVISION SOFTWARE SYSTEMS
K121075 · LLZ
3D Imaging Partners, Inc.
Radiology · 108d
Cleared Jul 26, 2012
GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY...
K120993 · JAQ
Varian Medical Systems, Inc.
Radiology · 115d
Cleared Jul 26, 2012
CLARISCT
K120753 · OAS
Icrco, Inc.
Radiology · 135d