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
5473–5496 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 08, 2013
OPTIMA CT520
K123596 · JAK
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 79d
Cleared Feb 08, 2013
DIAGNOSTIC ULTRASOUND SYSTEM
K123249 · IYN
Edan Instruments, Inc.
Radiology · 114d
Cleared Feb 08, 2013
SURGERY REHEARSAL PLATFORM
K123023 · LLZ
Surgical Theater, LLC
Radiology · 133d
Cleared Feb 07, 2013
M2 WRIST MRI SYSTEM
K120701 · LNH
Aspect Imaging, Ltd.
Radiology · 337d
Cleared Feb 06, 2013
SHEATHES STERILE ULTRASOUND GEL
K130041 · MUI
Sheathing Technologies, Inc.
Radiology · 29d
Cleared Feb 06, 2013
APLIO 500/400/300 V3.0
K123992 · IYN
Toshibamedical Systems Corporation
Radiology · 42d
Cleared Feb 06, 2013
CAAS INTRAVASCULAR
K123970 · LLZ
Pie Medical Imaging BV
Radiology · 42d
Cleared Feb 01, 2013
MICRODOSE SI
K123995 · MUE
Philips Digital Mammography Sweden AB
Radiology · 37d
Cleared Feb 01, 2013
E-CUBE 15
K123610 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 72d
Cleared Feb 01, 2013
INVIVO DENTAL
K123519 · LLZ
Anatomage, Inc.
Radiology · 78d
Cleared Feb 01, 2013
SYNGO, BREAST CARE
K123420 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 87d
Cleared Feb 01, 2013
VIVIX-S WIRELESS
K122865 · MQB
Vieworks Co., Ltd.
Radiology · 136d
Cleared Feb 01, 2013
PLANMED VERITY
K121418 · JAK
Planmed OY
Radiology · 266d
Cleared Jan 30, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA
K122928 · MQB
Rayence Co., Ltd.
Radiology · 128d
Cleared Jan 29, 2013
IMAGEQUBE
K124048 · LLZ
Intuitive Imaging Informatics, LLC
Radiology · 29d
Cleared Jan 29, 2013
TRACTUS TISSUEMAPPER REVIEWER APPLICATION
K123901 · LLZ
Tractus Corporation
Radiology · 42d
Cleared Jan 29, 2013
GE ECHOPAC
K123894 · LLZ
Ge Vingmed Ultrasound AS
Radiology · 42d
Cleared Jan 29, 2013
CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
K123873 · MUE
Hologic, Inc.
Radiology · 43d
Cleared Jan 29, 2013
BIOGRAPH MCT FAMILY
K123737 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 55d
Cleared Jan 29, 2013
A-SCAN PLUS CONNECT
K123349 · IYO
Accutome, Inc.
Radiology · 90d
Cleared Jan 29, 2013
PROCEDURE REHEARSAL STUDIO
K123269 · LLZ
Simbionix , Ltd.
Radiology · 102d
Cleared Jan 25, 2013
DECLIPSESPECT VIEWER
K123917 · IZD
Surgiceye GmbH
Radiology · 37d
Cleared Jan 24, 2013
POINT 500 HD POINT500C HD
K121800 · MUH
Pointnix Co., Ltd.
Radiology · 219d
Not Cleared Jan 23, 2013
FERRISCAN R2-MRI ANALYSIS SYSTEM
DEN130012 · PCS
Resonance Health Analysis Services...
Radiology · 21d