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
5929–5952 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 28, 2011
DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K113153 · IYO
Shenzhen Mindray Bio-Medical...
Radiology · 34d
Cleared Nov 23, 2011
CAROTID COIL GE 1.5T
K113280 · MOS
Tursiop Technologies, LLC
Radiology · 16d
Cleared Nov 23, 2011
SDX-4343CS
K112751 · MQB
Samsung Mobile Display Co., Ltd.
Radiology · 63d
Cleared Nov 23, 2011
MAGNETOM AERA AND MAGNETOM SKYRA
K111242 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 204d
Cleared Nov 23, 2011
INGENUITY TF PET/MR
K103483 · OUO
Philips Healthcare (Cleveland)
Radiology · 362d
Cleared Nov 22, 2011
INFINIX-CCI
K113052 · MQB
Toshiba America Medical Systems, In.C
Radiology · 40d
Cleared Nov 22, 2011
SYNGO AORTIC VALVEGUIDE SOFTWARE
K113027 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 42d
Cleared Nov 22, 2011
CLEARVISION
K112380 · MUH
Midmark Corp.
Radiology · 97d
Cleared Nov 22, 2011
FRAXION
K112210 · IYE
Medical Intelligence Medizintechnik GmbH
Radiology · 113d
Cleared Nov 22, 2011
SAFIRE
K103424 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 365d
Cleared Nov 18, 2011
SYNGO VIA MI WORKFLOWS
K113029 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 38d
Cleared Nov 18, 2011
CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING
K112768 · LHN
Calypso Medical Technologies, Inc.
Radiology · 57d
Cleared Nov 18, 2011
VITREA CT MYOCARDIAL ANALYSIS
K112531 · LLZ
Vital Images, Inc.
Radiology · 79d
Cleared Nov 18, 2011
ONCENTRA PROSTATE 4.0
K112420 · JAQ
Nucletron
Radiology · 87d
Cleared Nov 18, 2011
KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
K112132 · MQB
Medicatech USA
Radiology · 115d
Cleared Nov 18, 2011
CAROTID COIL
K112002 · MOS
Shanghai Chenguang Medical...
Radiology · 128d
Cleared Nov 18, 2011
ONCO TRAC MODEL 1, 2, 4
K111642 · LLZ
Translational Sciences Corporation
Radiology · 158d
Cleared Nov 18, 2011
MW100 (MAMMOGRAPHY) LCD MONITOR SYSTEM
K110596 · LLZ
Wide Corporation
Radiology · 261d
Cleared Nov 15, 2011
SONOSITE EDGE ULTRASOUND SYSTEM
K113156 · IYO
Sonosite,Inc.
Radiology · 20d
Cleared Nov 14, 2011
VARIAN HIGH ENERGY LINEAR ACCELERATOR
K112839 · IYE
Varian Medical Systems
Radiology · 47d
Cleared Nov 10, 2011
CT-GUIDE NEEDLE GUIDANCE SYSTEM
K113063 · JAK
Activiews, Ltd.
Radiology · 27d
Cleared Nov 10, 2011
DIGITAL FLAT PANEL X-RAY DETECTOR
K112558 · MQB
Samsung Mobile Display Co., Ltd.
Radiology · 69d
Cleared Nov 07, 2011
S6 DIAGNOSTIC ULTRASOUND SYSTEM
K112602 · IYN
Sonoscape Company Limited
Radiology · 61d
Cleared Nov 07, 2011
MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2
K112145 · LLZ
Totoku Electric Co., Ltd.
Radiology · 104d