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
4489–4512 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 16, 2015
UroNav (Version 2.0)
K153073 · LLZ
Invivo Corporation
Radiology · 25d
Cleared Nov 16, 2015
HICAT Air
K152661 · LLZ
Hicat GmbH
Radiology · 60d
Cleared Nov 13, 2015
Multitom Rax
K152928 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 39d
Cleared Nov 12, 2015
FUJIFILM SonoSite iViz Ultrasound System
K152983 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 34d
Cleared Nov 12, 2015
SOMATOM Emotion 6/16
K151752 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 136d
Cleared Nov 10, 2015
Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S
K153060 · MUH
Rayence Co., Ltd.
Radiology · 20d
Cleared Nov 10, 2015
CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors
K153058 · MQB
Careray Digital Medical System Co., Ltd.
Radiology · 20d
Cleared Nov 10, 2015
ATAL 9
K152151 · MQB
Atlaim Corporation
Radiology · 99d
Cleared Nov 09, 2015
Thermofit
K151946 · IYE
Orfit Industries
Radiology · 118d
Cleared Nov 06, 2015
Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System
K152567 · IYN
Ge Healthcare
Radiology · 58d
Cleared Nov 05, 2015
FDR D-EVO GL Flat Panel Detector System
K152138 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 97d
Cleared Nov 05, 2015
superDimension Navigation System
K151376 · JAK
Covidien, LLC
Radiology · 167d
Cleared Nov 04, 2015
NeuViz 128 Multi-slice CT Scanner System
K151383 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 166d
Cleared Nov 04, 2015
Ziostation2
K151212 · LLZ
Qi Imaging, LLC
Radiology · 182d
Cleared Nov 02, 2015
HS70A Diagnostic Ultrasound System
K152962 · IYN
Samsung Medison Co., Ltd.
Radiology · 26d
Cleared Nov 02, 2015
PROBEAT-V
K152592 · LHN
Hitachi, Ltd., Health Care Company
Radiology · 53d
Cleared Nov 02, 2015
Positron Emission Tomography (PET) and Computed Tomography (CT) System,...
K151403 · KPS
Neusoft Medical Systems Co., Ltd.
Radiology · 160d
Cleared Nov 02, 2015
syngo.CT Myocardial Perfusion
K150713 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 228d
Cleared Oct 30, 2015
Philips Lumify Diagnostic Ultrasound System
K152899 · IYN
Philips Healthcare, Inc.
Radiology · 29d
Cleared Oct 30, 2015
Lung Analysis Software
K151283 · JAK
Vital Images, Inc.
Radiology · 169d
Cleared Oct 30, 2015
SCENARIA Phase 3 Whole-body X-ray CT System
K150595 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 235d
Cleared Oct 29, 2015
M9/M9CV/M9T Diagnostic Ultrasound System
K152543 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 55d
Cleared Oct 29, 2015
Leksell Gamma Knife Perfexion
K151159 · IWB
Elekta Instrument AB
Radiology · 181d
Cleared Oct 27, 2015
SIGNA Pioneer
K153003 · LNH
Ge Healthcare
Radiology · 14d