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
4105–4128 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 22, 2016
MAGNETOM Avantofit, MAGNETOM Skyrafit
K162102 · LNH
Siemens Medi Cal Solutions, Inc.
Radiology · 116d
Cleared Nov 18, 2016
Dosimetry Check Version 5 Release 1
K162577 · IYE
Math Resolutions, LLC
Radiology · 64d
Cleared Nov 18, 2016
HyperBand
K162403 · LNH
Ge Medical Systems, LLC
Radiology · 81d
Cleared Nov 18, 2016
MAGNETOM ESSENZA
K161795 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 141d
Cleared Nov 18, 2016
Discovery NM 750b Bopsy
K160933 · IYX
Ge Healthcare
Radiology · 228d
Cleared Nov 17, 2016
LOGIQ E9, LOGIQ E9 XDClear 2.0
K163077 · IYN
GE Medical Systems Ultrasound and...
Radiology · 14d
Cleared Nov 17, 2016
ALOKA LISENDO 880
K162583 · IYN
Hitachi , Ltd.
Radiology · 63d
Cleared Nov 17, 2016
Heyman Packing Applicator Set
K160045 · JAQ
Varian Medical Systems, Inc.
Radiology · 314d
Cleared Nov 16, 2016
Xperius Ultrasound System
K163020 · IYN
Philips Health Care
Radiology · 16d
Cleared Nov 16, 2016
syngo Application Software
K162541 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 65d
Cleared Nov 16, 2016
Aixplorer
K161999 · IYN
Supersonic Imagine
Radiology · 119d
Cleared Nov 15, 2016
Optima XR240amx
K162990 · IZL
Ge Medical Systems, LLC
Radiology · 19d
Cleared Nov 15, 2016
Digital Diagnostic Mobile X-ray System
K162278 · IZL
Samsung Electronics Co., Ltd.
Radiology · 92d
Cleared Nov 15, 2016
CushionCast Moldable Cushions
K162265 · IYE
Izi Medical Products, LLC
Radiology · 96d
Cleared Nov 15, 2016
eUnity
K161515 · LLZ
Client Outlook, Inc.
Radiology · 166d
Cleared Nov 15, 2016
X-MIND trium
K160166 · OAS
De Gotzen S.R.L.
Radiology · 293d
Cleared Nov 10, 2016
i-CAT FLX V series / KaVo 3D eXam+ V series
K162085 · OAS
Imaging Sciences International
Radiology · 106d
Cleared Nov 10, 2016
IPS CaseDesigner
K161634 · LLZ
Nobel Biocare AB
Radiology · 149d
Cleared Nov 09, 2016
Raycast High Precision Lung Board Solution
K162862 · IYE
Orfit Industries NV
Radiology · 28d
Cleared Nov 07, 2016
dS Small Extremity 16CH 1.5T Coil
K162863 · MOS
Invivo Therapeutics Corporation
Radiology · 25d
Cleared Nov 04, 2016
I View and Imagen Sensor
K162619 · MUH
Trident S.R.L
Radiology · 45d
Cleared Nov 04, 2016
SuniIQ Digital Radiography System
K162585 · MUH
Suni Medical Imaging, Inc.
Radiology · 49d
Cleared Nov 04, 2016
Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy...
K162573 · KXK
Source Production and Equipment Co.,...
Radiology · 50d
Cleared Nov 04, 2016
D-SPECT Scanner, D-SPECT L Scanner
K161740 · KPS
Spectrum Dynamics Medical, Ltd.
Radiology · 133d