Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Radiology ×
15,695 results
1801–1824 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 01, 2022
Combined High Frequency X-ray Source
K222258 · IZL
Suzhou Powersite Electric Co., Ltd.
Radiology · 97d
Cleared Nov 01, 2022
Dolphin Blue Imaging
K221478 · LLZ
Patterson Dental Supply, Inc.
Radiology · 162d
Cleared Nov 01, 2022
Klarity SRS Baseplate, Klarity Promise Baseplate
K220539 · IYE
Klarity Medical & Equipment (GZ) Co.,...
Radiology · 249d
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