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 × Cleared only ×
15,676 results
1801–1824 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Oct 13, 2022
Wireless Probe Type Ultrasound Scanner (Model: CProbe
K211321 · IYN
Guangzhou Sonostar Technologies Co.,...
Radiology · 531d
Cleared Oct 11, 2022
SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L,...
K220169 · IYN
Bionet Co., Ltd.
Radiology · 264d
Cleared Oct 07, 2022
BriefCase
K220709 · QAS
Aidoc Medical , Ltd.
Radiology · 211d
Cleared Oct 07, 2022
MIM-Ablation
K220256 · QTZ
Mim Software, Inc.
Radiology · 249d
Cleared Oct 06, 2022
Garion Image-Intensified Fluoroscopic X-Ray System, Mobile
K222080 · OWB
Sg Healthcare Co, Ltd.
Radiology · 83d
Cleared Oct 06, 2022
Genius AI Detection 2.0
K221449 · QDQ
Hologic, Inc.
Radiology · 141d
Cleared Sep 30, 2022
Shield System
K222625 · OWB
Radiaction , Ltd.
Radiology · 30d