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
5137–5160 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 27, 2014
TARGET3D FUSION
K140033 · LLZ
Convergent Life Sciences, Inc.
Radiology · 51d
Cleared Feb 26, 2014
ST SENSE NV 8 ARRAY COIL
K140282 · MOS
Resonance Innovations, LLC
Radiology · 22d
Cleared Feb 26, 2014
EZONO 4000
K140254 · IYN
Ezono AG
Radiology · 26d
Cleared Feb 26, 2014
LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE
K133385 · LLZ
Broncus Medical, Inc.
Radiology · 113d
Cleared Feb 26, 2014
FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED...
K132889 · JAQ
Nucletron B.V.
Radiology · 163d
Cleared Feb 26, 2014
TRINIAS
K123508 · OWB
Shimadzu Corporation
Radiology · 470d
Cleared Feb 25, 2014
SYNGO.VIA MI WORKFLOWS
K133644 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Feb 25, 2014
SICAT FUNCTION
K133320 · LLZ
Sicat GmbH & Co. KG
Radiology · 120d
Cleared Feb 25, 2014
UP600 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM
K132690 · IYN
Qisda Corporation
Radiology · 181d
Cleared Feb 21, 2014
DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA
K133409 · MQB
Rayence Co., Ltd.
Radiology · 106d
Cleared Feb 21, 2014
ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1...
K132935 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 156d
Cleared Feb 21, 2014
LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE...
K132874 · JAQ
Nucletron B.V.
Radiology · 161d
Cleared Feb 21, 2014
FLAATZ 600 SERIES (FLAATZ 600/601)
K132842 · MQB
Drtech Corp.
Radiology · 164d
Cleared Feb 19, 2014
30.0 INCH COLOR LCD MONITOR CCL650I2 (CL30650, MD302C6)
K140214 · LLZ
Jvckenwood Corporation
Radiology · 22d
Cleared Feb 19, 2014
DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEM
K140030 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 44d
Cleared Feb 14, 2014
3MP COLOR LCD DISPLAY
K140108 · LLZ
Shenzhen Beacon Display Technology...
Radiology · 30d
Cleared Feb 14, 2014
3MP GRAYSCAKE LCD DISPLAY
K140103 · LLZ
Shenzhen Beacon Display Technology...
Radiology · 30d
Cleared Feb 14, 2014
MD302C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR
K133708 · LLZ
Nec Display Solutions , Ltd.
Radiology · 72d
Cleared Feb 12, 2014
LOGIQ E
K133533 · IYN
Ge Healthcare
Radiology · 86d
Cleared Feb 12, 2014
MDIXON-QUANT
K133526 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 89d
Cleared Feb 10, 2014
IMRI 1.5T AND IMRI 3T S
K133692 · LNH
Imris, Inc.
Radiology · 70d
Cleared Feb 10, 2014
AQUILION ONE VISION
K133497 · JAK
Toshibamedical Systems Corporation
Radiology · 88d
Cleared Feb 07, 2014
ECLIPSE TREATMENT PLANNING SYSTEM
K133247 · MUJ
Varian Medical Systems, Inc.
Radiology · 108d
Cleared Feb 06, 2014
CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION
K132824 · LLZ
Carestream Health, Inc.
Radiology · 150d