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
7153–7176 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 28, 2008
APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS
K072847 · KGI
Hologic, Inc.
Radiology · 176d
Cleared Mar 27, 2008
HD7 DIAGNOSTIC ULTRASOUND SYSTEM
K080548 · IYN
Phillips Medical Systems
Radiology · 28d
Cleared Mar 26, 2008
BELLA
K073262 · IZH
Beekley Corp.
Radiology · 127d
Cleared Mar 21, 2008
ZIEHM VISION 2
K073346 · JAK
Ziehm Imaging, Inc.
Radiology · 113d
Cleared Mar 21, 2008
M5 DIAGNOSTIC ULTRASOUND SYSTEM
K080640 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 15d
Cleared Mar 20, 2008
COLOR LCD MONITOR, MODEL RADIFORCE RX211
K080457 · LLZ
Eizo Nanao Corporation
Radiology · 29d
Cleared Mar 19, 2008
KANTERON DICOM STATION (KDS), MODEL 3.0
K073176 · LLZ
Monica Veytia
Radiology · 127d
Cleared Mar 19, 2008
TRAUMACAD VERSION 2.0
K073714 · LLZ
Orthocrat, Ltd.
Radiology · 79d
Cleared Mar 14, 2008
QUANTITATIVE NEUROQ 3.0
K072307 · KPS
Syntermed, Inc.
Radiology · 210d
Cleared Mar 14, 2008
RX DC X-RAY UNIT
K080076 · EHD
Cefla S.C.R.L.
Radiology · 63d
Cleared Mar 14, 2008
MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM
K080211 · JAK
Toshiba America Medical Systems, In.C
Radiology · 45d
Cleared Mar 13, 2008
ATLANTIS 018 PERIPHERAL IMAGING CATHETER
K073623 · ITX
Boston Scientific Corp
Radiology · 78d
Cleared Mar 13, 2008
NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0
K080540 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 15d
Cleared Mar 12, 2008
AMICAS VISION SERIES PACS, MODEL 5.5
K073526 · LLZ
Amicas, Inc.
Radiology · 86d
Cleared Mar 11, 2008
MODIFICATION TO VIEWMATE SYSTEM
K073709 · IYN
Ep Medsystems
Radiology · 71d
Cleared Mar 11, 2008
SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC,...
K080087 · KNG
Edan Instruments, Inc.
Radiology · 60d
Cleared Mar 11, 2008
ATLANTIS PVIMAGING CATHETER, MODEL H749364560
K080272 · ITX
Boston Scientific Corp
Radiology · 39d
Cleared Mar 10, 2008
OMNI-VUE SYSTEM
K073062 · LLZ
Genesis Digital Imaging, Inc.
Radiology · 132d
Cleared Mar 10, 2008
MRJ EXTENDED
K080098 · LNH
Paramed S.R.L.
Radiology · 56d
Cleared Mar 10, 2008
HFO SHOULDER COIL
K080120 · MOS
Philips Medical Systems MR Finland
Radiology · 53d
Cleared Mar 10, 2008
5 MEGAPIXEL MONOCHROME LCD MONITOR, MODEL RADIFORCE GS520
K080422 · LLZ
Eizo Nanao Corporation
Radiology · 24d
Cleared Mar 04, 2008
QPLAQUE MR
K073156 · LNH
Medis Medical Imaging Systems BV
Radiology · 117d
Cleared Feb 29, 2008
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
K072683 · JAD
Xoft, Inc.
Radiology · 161d
Cleared Feb 29, 2008
SYNGO IMAGING CCF VA10A
K073418 · LLZ
Siemens AG Medical Solutions
Radiology · 86d