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
5905–5928 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 25, 2012
DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC...
K113632 · IYO
Shenzhen Mindray Bio-Meidcal...
Radiology · 51d
Cleared Jan 25, 2012
SUN 125C IONIZATION CHAMBER
K112981 · LHN
Sun Nuclear Corp.
Radiology · 111d
Cleared Jan 25, 2012
SWISSMEDA DENTAL PLANNING SYSTEM
K112251 · LLZ
Swissmeda AG
Radiology · 173d
Cleared Jan 17, 2012
HYPERION
K113497 · MUH
Cefla S.C. Cefla Dental Group
Radiology · 53d
Cleared Jan 17, 2012
AERODR SYSTEM WITH P-21
K113248 · KPR
Konica Minolta Medical & Graphic, Inc.
Radiology · 75d
Cleared Jan 13, 2012
OPTIMA MR450W
K113490 · LNH
Ge Medical Systems, LLC
Radiology · 51d
Cleared Jan 13, 2012
VANTAGE TITAN 3T
K113093 · LNH
Toshibamedical Systems Corporation
Radiology · 86d
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