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
3913–3936 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 26, 2017
FFR V2.5
K170133 · IYO
Philips Volcano
Radiology · 129d
Cleared May 26, 2017
SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System
K163140 · OWB
Gemss Medical Systems Co., Ltd.
Radiology · 198d
Cleared May 25, 2017
LCD Monitor (MD310C, MD310G, MD210G)
K170944 · PGY
Benq Corporation
Radiology · 56d
Cleared May 24, 2017
AS-10, CXDI-401RF
K171194 · OWB
Canon, Inc.
Radiology · 30d
Cleared May 24, 2017
UNiD Spine Analyzer
K170172 · LLZ
Medicrea International
Radiology · 125d
Cleared May 24, 2017
vascuCAP
K163071 · LLZ
Elucid Bioimaging, Inc.
Radiology · 203d
Cleared May 22, 2017
Pinpoint GT Needle Guide Kits
K171348 · ITX
C.R. Bard, Inc.
Radiology · 14d
Cleared May 22, 2017
Hybrid3D
K163394 · KPS
Hermes Medical Solutions AB
Radiology · 168d
Cleared May 19, 2017
OEC Elite
K170752 · OWB
Oec Medical Systems, Inc.
Radiology · 67d
Cleared May 19, 2017
E5 Series Digital Color Doppler Ultrasound System
K170303 · IYN
Sonoscape Medical Corp.
Radiology · 108d
Cleared May 19, 2017
BEAMSCAN
K161807 · IYE
Ptw-Freiburg Physikalisch...
Radiology · 322d
Cleared May 17, 2017
Nexus DR Digital X-ray Imaging System
K171138 · MQB
Varex Imaging Corporation
Radiology · 29d
Cleared May 17, 2017
QuantX
K170195 · LLZ
Quantitative Insights, Inc.
Radiology · 114d
Cleared May 17, 2017
Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT...
K170078 · IYN
Medisono, LLC
Radiology · 128d
Cleared May 17, 2017
Dynamika
K161601 · LLZ
Image Analysis Limited
Radiology · 342d
Cleared May 16, 2017
A-View
K170338 · ITX
Stroke2prevent B.V.
Radiology · 103d
Cleared May 16, 2017
iSR'obot Biopsy Kit
K163502 · ITX
Biobot Surgical Pte., Ltd.
Radiology · 153d
Cleared May 15, 2017
EVS 2430W, EVS 2430GW
K171137 · MQB
DRTECH Corporation
Radiology · 28d
Cleared May 15, 2017
SPiN Thoracic Navigation System
K170023 · JAK
Veran Medical Technologies, Inc.
Radiology · 132d
Cleared May 12, 2017
GM85
K171119 · IZL
Samsung Electronics Co., Ltd.
Radiology · 28d
Cleared May 11, 2017
GMR40
K171085 · MQB
Neurologica Corporation, A Subsidiary OF
Radiology · 29d
Cleared May 11, 2017
SurgiCase Viewer
K170419 · LLZ
Materialise NV
Radiology · 87d
Cleared May 11, 2017
Lung Vision
K163622 · LLZ
Bodyvision Medical , Ltd.
Radiology · 140d
Cleared May 11, 2017
Longitudinal Brain Imaging (LoBI) application
K163250 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 174d