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
3169–3192 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 22, 2019
OARtrac System
K182395 · NZT
Radialdyne, LLC
Radiology · 199d
Cleared Mar 20, 2019
ACUSON S3000, S2000 Diagnostic Ultrasound System
K183575 · IYN
Siemens Healthineers
Radiology · 89d
Cleared Mar 20, 2019
ABSOLU
K183414 · IYO
Quantel Medical
Radiology · 100d
Cleared Mar 19, 2019
MIM on Linux
K190379 · LLZ
Mim Software, Inc.
Radiology · 28d
Cleared Mar 19, 2019
SIS Software version 3.3.0
K183019 · LLZ
Surgical Information Sciences, Inc.
Radiology · 139d
Cleared Mar 15, 2019
FUJIFILM Sonosite Vevo MD Imaging System
K190476 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 16d
Cleared Mar 15, 2019
SonialVision G4
K190373 · JAA
Shimadzu Corporation
Radiology · 24d
Cleared Mar 15, 2019
Star-X, Intraoral X-ray System
K190357 · EHD
Hdx Will Corp.
Radiology · 28d
Cleared Mar 15, 2019
Vantage Galan 3T, MRT-3020/A9, V5.0
K183657 · LNH
Canon Medical Systems Corporation
Radiology · 78d
Cleared Mar 15, 2019
MOBILETT Elara Max
K182639 · IZL
Siemens Medi Cal Solutions, Inc.
Radiology · 172d
Cleared Mar 14, 2019
PathVisionXL
K183142 · MWP
Faxitron Bioptics, LLC
Radiology · 121d
Cleared Mar 13, 2019
Enhanced Feature Software Pack CXDI Series
K190368 · MQB
Canon, Inc.
Radiology · 26d
Cleared Mar 13, 2019
BIOK7600 Flat Panel Detector
K190311 · MQB
Biokinemetrics, Inc.
Radiology · 29d
Cleared Mar 13, 2019
BIOK7600W Wireless Flat Panel Detector
K190300 · MQB
Biokinemetrics, Inc.
Radiology · 29d
Cleared Mar 13, 2019
GammaTile
K190296 · KXK
Gt Medical Technologies
Radiology · 30d
Cleared Mar 13, 2019
JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD...
K183492 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 86d
Cleared Mar 08, 2019
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A...
K190206 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 32d
Cleared Mar 08, 2019
RadiForce MX216
K190153 · PGY
Eizo Corporation
Radiology · 37d
Cleared Mar 08, 2019
Nexus DR Digital X-ray Imaging System
K190146 · MQB
Varex Imaging Corporation
Radiology · 38d
Cleared Mar 08, 2019
EchoSure Diagnostic Ultrasound System
K190039 · IYO
Sonavex, Inc.
Radiology · 59d
Cleared Mar 08, 2019
NewTom 5G XL
K183448 · JAK
Cefla S.C.
Radiology · 86d
Cleared Mar 08, 2019
cmTriage
K183285 · QFM
Curemetrix, Inc.
Radiology · 102d
Cleared Mar 08, 2019
RADMAX Digital Imaging Software
K182537 · LLZ
DRGEM Corporation
Radiology · 175d
Cleared Mar 06, 2019
PLANET Onco Dose
K182966 · LLZ
Dosisoft
Radiology · 131d