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
5209–5232 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 16, 2013
SONOSITE EDGE ULTRASOUND SYSTEM
K133454 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 34d
Cleared Dec 16, 2013
FUSIONSYNC, CHIMAERA FUSIONSYNC
K132963 · LLZ
Chimaera GmbH
Radiology · 87d
Cleared Dec 16, 2013
2D PERFUSION
K132147 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 158d
Cleared Dec 13, 2013
S-SCAN
K131996 · LNH
Esaote, S.P.A.
Radiology · 168d
Cleared Dec 13, 2013
MICRODOSE SI
K130704 · MUE
Philips Digital Mammography Sweden AB
Radiology · 273d
Cleared Dec 13, 2013
HEPAFAT SCAN
K122035 · LNH
Resonance Health Analysis Services...
Radiology · 520d
Cleared Dec 12, 2013
MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A
K133435 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 34d
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