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
8113–8136 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 20, 2005
GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN
K050963 · MOT
Mds Nordion
Radiology · 32d
Cleared May 13, 2005
FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
K051025 · JAA
Hologic, Inc.
Radiology · 21d
Cleared May 13, 2005
ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM
K051139 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 9d
Cleared May 12, 2005
ESSENPACS
K051081 · LLZ
Cymed Engineering, Inc.
Radiology · 15d
Cleared May 05, 2005
ACCUCHANGER
K043409 · IYE
Direx Systems Corp.
Radiology · 146d
Cleared May 05, 2005
IMORGON ULTRASOUND PACS SOLUTIONS
K050736 · LLZ
Sea Ridge Software, Inc.
Radiology · 45d
Cleared May 05, 2005
O-ARM IMAGING SYSTEM
K050996 · OXO
Breakaway Imaging, LLC
Radiology · 15d
Cleared May 05, 2005
DOPPLER-BOX
K051085 · IYN
Compumedics Germany Gmgh
Radiology · 7d
Cleared Apr 27, 2005
CENTRION 500 C-ARM SYSTEM
K050866 · JAA
Osteosys Co.,Ltd
Radiology · 22d
Cleared Apr 27, 2005
DIGITAL RADIOGRAPHY MODEL CXDI-40EG
K050987 · MQB
Canon, Inc.
Radiology · 8d
Cleared Apr 26, 2005
20.8-INCH (53CM) COLOR LCD MONITOR, MODELS CDL2112A, CCL350I & DV3MC-HB
K050619 · LLZ
Totoku Electric Co., Ltd.
Radiology · 47d
Cleared Apr 26, 2005
XACT.CARDIAC & XPRESS.CARDIAC
K050815 · KPS
Ultraspect , Ltd.
Radiology · 26d
Cleared Apr 22, 2005
21.3-INCH (54CM) MONOCHROME LCD MONITOR, MODELS MDL2109A, ME251I & DV2MM-HB
K050617 · LLZ
Totoku Electric Co., Ltd.
Radiology · 43d
Cleared Apr 21, 2005
21.3-INCH (54CM) COLOR LCD MONITOR, MODELS CDL2113A, CCL250I & DV2MC-HB
K050616 · LLZ
Totoku Electric Co., Ltd.
Radiology · 42d
Cleared Apr 21, 2005
QBRAIN
K050703 · LLZ
Medis Medical Imaging Systems BV
Radiology · 34d
Cleared Apr 21, 2005
KAVO ERGOCOM/ERGOCAM
K050744 · LLZ
Kavo America Corporation
Radiology · 30d
Cleared Apr 21, 2005
IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X
K050751 · LLZ
Agfa Corp.
Radiology · 29d
Cleared Apr 21, 2005
AGFA CR50.0
K050810 · MQB
Agfa Corp.
Radiology · 21d
Cleared Apr 18, 2005
SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM
K050724 · ITX
C.R. Bard, Inc.
Radiology · 28d
Cleared Apr 15, 2005
SMARTDOP 45 VASCULAR DOPPLER
K050601 · DPW
Koven Technology, Inc.
Radiology · 37d
Cleared Apr 14, 2005
SYNGO BODY PERFUSION-CT
K050867 · JAK
Siemens AG
Radiology · 8d
Cleared Apr 08, 2005
HRW-63-8 WRIST ARRAY COIL
K050622 · MOS
Mri Devices Corporation
Radiology · 29d
Cleared Apr 08, 2005
TRAXYLOC-1 SYSTEM
K050663 · IZH
Traxyz Medical, Inc.
Radiology · 24d
Cleared Apr 08, 2005
FLXIS
K050692 · JAA
Philips Medical Systems North America...
Radiology · 22d