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
5185–5208 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 12, 2013
SYNC-RX SYSTEM
K132558 · OWB
Volcano Corporation
Radiology · 119d
Cleared Dec 12, 2013
MYOPERFUSION
K132523 · JAK
Toshibamedical Systems Corporation
Radiology · 122d
Cleared Dec 12, 2013
PLATINUM DRF IMAGING SYSTEM
K131766 · JAA
Apelem-Dms Group
Radiology · 178d
Cleared Dec 11, 2013
SIDEXIS 4
K132773 · LLZ
Sirona Dental Systems GmbH
Radiology · 97d
Cleared Dec 09, 2013
SYNGO.PLAZA VB10A
K132532 · LLZ
Siemens AG Healthcare
Radiology · 119d
Cleared Dec 05, 2013
ZIEHM VISION RFD
K132904 · JAA
Ziehm Imaging GmbH
Radiology · 80d
Cleared Dec 04, 2013
MYLABSEVEN 6400, MYLABALPHA 7400
K132466 · IYN
Esaote, S.P.A.
Radiology · 119d
Cleared Dec 03, 2013
21.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358)
K133185 · LLZ
Jvckenwood Corporation
Radiology · 47d
Cleared Dec 03, 2013
21.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258)
K133181 · LLZ
Jvckenwood Corporation
Radiology · 47d
Cleared Dec 03, 2013
M-VU BREAST DENSITY
K132742 · LLZ
Vucomp, Inc.
Radiology · 91d
Cleared Nov 29, 2013
LESSRAY
K132970 · OWB
Saferay Spine, LLC
Radiology · 67d
Cleared Nov 27, 2013
UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM
K133329 · IYN
Samsung Medison Co., Ltd.
Radiology · 29d
Cleared Nov 27, 2013
E-CUBE 7
K132687 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 91d
Cleared Nov 27, 2013
MYLABSEVEN, MYLABALPHA
K132231 · IYN
Esaote, S.P.A.
Radiology · 132d
Cleared Nov 27, 2013
JUSHA-M52C MEDICAL DISPLAY
K131390 · LLZ
Nanjing Jusha Display Technology Co.,...
Radiology · 197d
Cleared Nov 25, 2013
CHARRUAPACS SYSTEM
K133357 · LLZ
Charruasoft SA
Radiology · 25d
Cleared Nov 25, 2013
TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA
K132544 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 104d
Cleared Nov 25, 2013
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
K132509 · MQB
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 105d
Cleared Nov 22, 2013
MAGNETOM PRISMA, MAGNETOM PRISMA FIT
K132119 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 136d
Cleared Nov 20, 2013
MONACO
K132971 · MUJ
Impac Medical Systems, Inc.
Radiology · 58d
Cleared Nov 20, 2013
I2C
K132847 · LHN
Ion Beam Applications S.A.
Radiology · 70d
Cleared Nov 20, 2013
MULTICAM 3000 ECO
K132347 · KPS
Inter Medical Medizintechnik GmbH
Radiology · 114d
Cleared Nov 20, 2013
MRI MARKER
K131689 · KXK
C4 Imaging, LLC
Radiology · 163d
Cleared Nov 19, 2013
DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM
K132779 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 75d