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
1729–1752 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 31, 2022
CW60N
K222722 · PGY
Wide Corporation
Radiology · 53d
Cleared Oct 31, 2022
CL24N
K222717 · PGY
Wide Corporation
Radiology · 53d
Cleared Oct 28, 2022
Stage
K223079 · LNH
Spintech, Inc.
Radiology · 28d
Cleared Oct 28, 2022
Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20,...
K222191 · IYN
Supersonic Imagine
Radiology · 98d
Cleared Oct 27, 2022
uMR Omega with uWS-MR-MRS
K220332 · LNH
Shanghai United Imaging Healthcare...
Radiology · 265d
Cleared Oct 26, 2022
DigiX FDX
K223060 · KPR
Allengers Medical Systems Limited
Radiology · 26d
Cleared Oct 26, 2022
EzRay Air 2 Wall (Model: VEX-S350W)
K223058 · EHD
VATECH Co., Ltd.
Radiology · 26d
Cleared Oct 26, 2022
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife...
K222047 · IWB
Elekta Solutions AB
Radiology · 106d
Cleared Oct 25, 2022
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction...
K222968 · LNH
Canon Medical Systems Corporation
Radiology · 28d
Cleared Oct 25, 2022
3Dicom MD
K222470 · LLZ
Singular Health Pty, Ltd.
Radiology · 70d
Cleared Oct 25, 2022
Leltek Ultrasound Imaging System (Model: LU700 Series)
K222365 · IYN
Leltek, Inc.
Radiology · 82d
Cleared Oct 25, 2022
EndoNaut
K222070 · OWB
Therenva Sas
Radiology · 103d
Cleared Oct 21, 2022
Viz LVO ContaCT
K223042 · QAS
Viz. Ai, Inc.
Radiology · 22d
Cleared Oct 21, 2022
IntraOp VSP Software Device
K213128 · LLZ
Xironetic, LLC
Radiology · 389d
Cleared Oct 20, 2022
Mercu 1717V
K222886 · MQB
Iray Technology Taicang , Ltd.
Radiology · 27d
Cleared Oct 20, 2022
AI-Rad Companion (Musculoskeletal)
K222361 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 77d
Cleared Oct 18, 2022
Spine CAMP™
K221632 · QIH
Medical Metrics, Inc.
Radiology · 134d
Cleared Oct 17, 2022
Digital Radiography CXDI-Pro, Digital Radiography D1
K222855 · MQB
Canon, Inc.
Radiology · 26d
Cleared Oct 14, 2022
Vitrea CT Cardiac Analysis
K222662 · LLZ
Canon Medical Informatics, Inc.
Radiology · 42d
Cleared Oct 14, 2022
16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast...
K222407 · MOS
Neocoil, LLC
Radiology · 66d
Cleared Oct 14, 2022
syngo.via View&GO
K221501 · LLZ
Siemens Healthcare GmbH
Radiology · 144d
Cleared Oct 14, 2022
AI-Rad Companion Organs RT
K221305 · QKB
Siemens Medical Solutions USA, Inc.
Radiology · 162d
Cleared Oct 14, 2022
X-CUBE 70, X-CUBE 90
K221093 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 184d
Cleared Oct 13, 2022
X-CUBE 50, X-CUBE 60
K220857 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 204d