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
5881–5904 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 13, 2012
ACQA
K113086 · KPS
Texas Medical Imaging Consultants
Radiology · 87d
Cleared Jan 06, 2012
RADIANCE
K112060 · MUJ
Gmv Aerospace and Defence S.A.
Radiology · 171d
Cleared Jan 06, 2012
TOUCHPACS SUITE
K112008 · LLZ
Touch Medical Solutions, Inc.
Radiology · 177d
Cleared Jan 06, 2012
SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE
K111861 · LLZ
Siemens Medical Systems USA
Radiology · 190d
Cleared Jan 06, 2012
SONOTT FLOWLAB(R)
K111730 · DPW
Em-Tec GmbH
Radiology · 200d
Cleared Jan 05, 2012
ORTHOSCAN MOBILE DI MINI C-ARM
K113708 · OXO
Orthoscan, Inc.
Radiology · 20d
Cleared Jan 05, 2012
DIGITAL X-RAY IMAGING SYSTEM
K111103 · MUH
Rf Co., Ltd.
Radiology · 260d
Cleared Dec 30, 2011
VISIA DYNAMIC REVIEW
K113337 · LNH
Mevis Medical Solutions AG
Radiology · 46d
Cleared Dec 29, 2011
GE LOGIQ I, LOGIQ E AND VIVID E
K113690 · IYN
Ge Healthcare
Radiology · 14d
Cleared Dec 29, 2011
SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT
K113680 · IYO
Soma Access Systems, LLC
Radiology · 14d
Cleared Dec 29, 2011
DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA
K113630 · MQB
Rayence Co., Ltd.
Radiology · 21d
Cleared Dec 29, 2011
MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEM
K113381 · IYN
Samsung Medison Co., Ltd.
Radiology · 43d
Cleared Dec 29, 2011
SOMATOM DEFINITION FLASH
K113342 · JAK
Siemens Medical Systems, Inc.
Radiology · 45d
Cleared Dec 29, 2011
SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING
K112778 · IYE
Varian Medical Systems
Radiology · 94d
Cleared Dec 28, 2011
DELTAVIEW MODEL 2.1
K111776 · LLZ
Riverain Medical Group,Llc
Radiology · 188d
Cleared Dec 27, 2011
PROCEDURE REHEARSAL STUDIO(TM)
K112387 · LLZ
Simbionix , Ltd.
Radiology · 131d
Cleared Dec 23, 2011
21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)
K113443 · LLZ
Totoku Electric Co., Ltd.
Radiology · 32d
Cleared Dec 23, 2011
1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL
K111673 · MOS
Invivo Corporation
Radiology · 191d
Cleared Dec 23, 2011
KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM
K110717 · MUE
Konica Minolta Medical & Graphic, Inc.
Radiology · 283d
Cleared Dec 22, 2011
SYNAPSE MPR FUSION
K113244 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 50d
Cleared Dec 22, 2011
TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER
K112776 · MUJ
Tomotherapy Incorporated
Radiology · 87d
Cleared Dec 22, 2011
THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA...
K112109 · LLZ
Ortho Kinematics, Inc.
Radiology · 153d
Cleared Dec 22, 2011
CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER
K111324 · MUE
Agfa Healthcare N.V.
Radiology · 225d
Cleared Dec 22, 2011
SENOGRAPHE DS, SENOGRAPHE ESSENTIAL
K110798 · MUE
General Electric Company
Radiology · 275d