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
2809–2832 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 25, 2020
Arterys MICA
K192437 · QIH
Arterys, Inc.
Radiology · 201d
Cleared Mar 23, 2020
RadiForce RX1270, RadiForce RX1270-AR
K200485 · PGY
Eizo Corporation
Radiology · 25d
Cleared Mar 20, 2020
Symbia 6.7
K200474 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 23d
Cleared Mar 20, 2020
Hepatic VCAR
K193281 · JAK
GE Medical Systems SCS
Radiology · 114d
Cleared Mar 20, 2020
MULTIX Impact
K193089 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 135d
Cleared Mar 18, 2020
VIVIX-S VW
K200418 · MQB
Vieworks Co., Ltd.
Radiology · 27d
Cleared Mar 18, 2020
Viz ICH
K193658 · QAS
Viz. Ai, Inc.
Radiology · 79d
Cleared Mar 17, 2020
Shear Wave Quantificational Ultrasound Diagnostic System
K200136 · IYO
Wuxi Hisky Medical Technologies Co.,...
Radiology · 56d
Cleared Mar 16, 2020
Al-Rad Companion (Musculoskeletal)
K193267 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 111d
Cleared Mar 16, 2020
OptikView GUP2103CMI
K191705 · PGY
The Linden Group Corp
Radiology · 264d
Cleared Mar 13, 2020
CS 9600
K200183 · OAS
Trophy
Radiology · 49d
Cleared Mar 13, 2020
32HL512D
K192925 · PGY
Lg Electronics.Inc
Radiology · 149d
Cleared Mar 13, 2020
EzOrtho
K192888 · LLZ
Ewoosoft Co., Ltd.
Radiology · 155d
Cleared Mar 12, 2020
SonoVision Ultrasound Imaging System
K192388 · IYN
Tissue Differentiation Intelligence, LLC
Radiology · 191d
Cleared Mar 12, 2020
RefleXion Medical Radiotherapy System
K190978 · IYE
Reflexion Medical, Inc.
Radiology · 332d
Cleared Mar 11, 2020
MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit
K192924 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 147d
Cleared Mar 09, 2020
DR 600 with Tomosynthesis
K193262 · IZF
Agfa N.V.
Radiology · 104d
Cleared Mar 09, 2020
syngo.CT Lung CAD
K193216 · OEB
Siemens Medi Cal Solutions, Inc.
Radiology · 109d
Cleared Mar 09, 2020
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
K192574 · LNH
Canon Medical Systems Corporation
Radiology · 172d
Cleared Mar 06, 2020
Insight Enhanced DRF Digital Imaging System
K200396 · JAA
Imaging Engineering, LLC
Radiology · 17d
Cleared Mar 06, 2020
EPIQ Diagnostic Ultrasound System
K200304 · IYN
Philips Ultrasound, Inc.
Radiology · 29d
Cleared Mar 05, 2020
TrackX
K200360 · OWB
Track X Technology, LLC
Radiology · 21d
Cleared Mar 05, 2020
Transpara
K193229 · QDQ
Screenpoint Medical B.V.
Radiology · 104d
Cleared Mar 05, 2020
ProVecta 3D Prime Ceph
K193139 · OAS
Durr Dental SE
Radiology · 113d