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
361–384 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 03, 2026
Diagnostic X-Ray Equipment Model POCT22
K252909 · EHD
Ningbo Runyes Medical Instrument Co.,...
Radiology · 144d
Cleared Feb 02, 2026
TAP2D
K252649 · IZF
Nano-X Imaging , Ltd.
Radiology · 165d
Cleared Jan 30, 2026
RevealAI-Lung
K251769 · POK
Precision Medical Ventures, Inc. Dba...
Radiology · 234d
Cleared Jan 29, 2026
Neurophet AQUA AD Plus
K252496 · QIH
Neurophet., Inc.
Radiology · 174d
Cleared Jan 29, 2026
Surgical Reality Viewer
K252091 · QIH
Medicalvr B.V.
Radiology · 210d
Cleared Jan 28, 2026
Seg Pro V3 (RT-300)
K251306 · QKB
Ever Fortune.Ai, Co., Ltd.
Radiology · 275d
Cleared Jan 27, 2026
BriefCase-Triage
K251195 · QAS
Aidoc Medical , Ltd.
Radiology · 285d
Cleared Jan 26, 2026
Ascent3T Neonatal Magnetic Resonance Imaging System
K253499 · LNH
Eyas Medical Imaging, Inc.
Radiology · 89d
Cleared Jan 23, 2026
3.0T AIR 32CH HNA
K253738 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 60d
Cleared Jan 23, 2026
AccuContour 4.0
K251351 · QKB
Manteia Technologies Co., Ltd.
Radiology · 268d
Cleared Jan 22, 2026
AV Vascular
K253735 · QIH
Philips Medical Systems Nederland B.V.
Radiology · 59d
Cleared Jan 22, 2026
AI-Rad Companion Brain MR
K253057 · QIH
Siemens Healthcare GmbH
Radiology · 122d
Cleared Jan 21, 2026
Halcyon, Ethos Radiotherapy System (5.0)
K252977 · IYE
Varian Medical Systems, Inc.
Radiology · 126d
Cleared Jan 20, 2026
Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System
K253597 · IYN
Canon Medical Systems Corporation
Radiology · 63d
Cleared Jan 20, 2026
uCT 780 with uWS-CT-Dual Energy Analysis
K253173 · JAK
Shanghai United Imaging Healthcare...
Radiology · 116d
Cleared Jan 20, 2026
DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35...
K250954 · KPR
Carestream Health
Radiology · 298d
Cleared Jan 16, 2026
Azurion R3.1
K254186 · OWB
Philips Medical Systems B.V.
Radiology · 24d
Cleared Jan 16, 2026
Imagine® Enterprise Suite
K252634 · QIH
Softlink International Private Limited
Radiology · 149d
Cleared Jan 16, 2026
qXR-Detect
K251934 · MYN
Qure.Ai Technologies
Radiology · 206d
Cleared Jan 15, 2026
BIOGRAPH One
K253023 · OUO
Siemens Healthineers AG
Radiology · 118d
Cleared Jan 15, 2026
Diagnocat
K252934 · MYN
DGNCT, LLC
Radiology · 122d
Cleared Jan 15, 2026
EMLA (Elekta Evo)
K252188 · IYE
Elekta Solutions AB
Radiology · 185d
Cleared Jan 14, 2026
dS Base 1.5T
K254190 · MOS
Philips Medical Systems Nederland B.V.
Radiology · 22d
Cleared Jan 14, 2026
ExacTrac Dynamic (2.0.2)
K254010 · IYE
Brainlab SE
Radiology · 30d