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
5281–5304 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 29, 2013
CR 12-X DIGITIZER
K131408 · MQB
Agfa Healthcare N.V.
Radiology · 106d
Cleared Aug 29, 2013
OMNI-VUE 2 SYSTEM
K130374 · LLZ
Genesis Digital Imaging, Inc.
Radiology · 196d
Cleared Aug 29, 2013
MAVEN PRO
K130242 · LLZ
Nsequence
Radiology · 210d
Cleared Aug 29, 2013
SYNGO CT PULMO 3D
K123540 · JAK
Siemens Medical Systems, Inc.
Radiology · 283d
Cleared Aug 28, 2013
SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM
K131582 · JAD
Sensus Healthcare
Radiology · 89d
Cleared Aug 28, 2013
XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM
K131507 · IYN
Toshibamedical Systems Corporation
Radiology · 96d
Cleared Aug 26, 2013
LOGIQ S8
K131527 · IYN
Ge Healthcare
Radiology · 90d
Cleared Aug 22, 2013
AERODR SYSTEM WITH P-31
K130936 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 140d
Cleared Aug 21, 2013
EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
K132304 · IYN
Philips Ultrasound, Inc.
Radiology · 28d
Cleared Aug 21, 2013
3DVH
K131862 · IYE
Sun Nuclear Corporation
Radiology · 58d
Cleared Aug 21, 2013
JUSHA-M32 MEDICAL DISPLAY
K131391 · LLZ
Nanjing Jusha Display Technology Co.,...
Radiology · 99d
Cleared Aug 21, 2013
CORVIEW
K131158 · LLZ
Marrek, Inc.
Radiology · 119d
Cleared Aug 20, 2013
UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM
K132228 · IYO
Samsung Medison Co., Ltd.
Radiology · 34d
Cleared Aug 20, 2013
MAPCHECK2, ARCCHECK
K131466 · IYE
Sun Nuclear Corporation
Radiology · 91d
Cleared Aug 20, 2013
SURESUBTRACTION ORTHO
K130960 · JAK
Toshibamedical Systems Corporation
Radiology · 137d
Cleared Aug 20, 2013
SYNGO.MR GENERAL
K130749 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 154d
Cleared Aug 16, 2013
SYMBIA
K131634 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 73d
Cleared Aug 15, 2013
DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS
K132341 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 20d
Cleared Aug 15, 2013
ORTHOVISION
K131570 · LLZ
Ewoosoft Co., Ltd.
Radiology · 77d
Cleared Aug 15, 2013
LVIVO EF SYSTEM
K130779 · LLZ
Diacardio, Ltd.
Radiology · 147d
Cleared Aug 09, 2013
QLAB QUANTIFICATION SOFTWARE
K132165 · LLZ
Philips Ultrasound, Inc.
Radiology · 28d
Cleared Aug 07, 2013
ACTIVE BREATHING COORDINATOR
K131313 · IYE
Aktina Medical Corp.
Radiology · 92d
Cleared Aug 06, 2013
THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0
K130743 · LLZ
Ortho Kinematics, Inc.
Radiology · 140d
Cleared Aug 05, 2013
EPIDOSE
K131704 · IYE
Sun Nuclear Corporation
Radiology · 55d