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
313–336 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 13, 2026
Aquilion ServeSP (TSX-307B) V2.0
K260078 · JAK
Canon Medical Systems Corporation
Radiology · 60d
Cleared Mar 13, 2026
Embrace Neonatal MRI System
K254277 · LNH
Aspect Imaging, Ltd.
Radiology · 73d
Cleared Mar 13, 2026
Aeka Imaging
K253111 · LLZ
Good Methods Global, Inc.
Radiology · 170d
Cleared Mar 13, 2026
InferCare RECIST
K252261 · QIH
Beijing Infervision Healthcare...
Radiology · 235d
Cleared Mar 13, 2026
Extremity CT Imaging System
K252249 · JAK
Mars Bioimaging , Ltd.
Radiology · 238d
Cleared Mar 12, 2026
Dental X-RAY Unit (AJX200)
K252110 · EHD
Guangzhou Ajax Medical Equipment Co.,...
Radiology · 248d
Cleared Mar 12, 2026
Mimics Thoracic Planner
K251964 · LLZ
Materialise NV
Radiology · 259d
Cleared Mar 11, 2026
Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System
K253185 · IZL
Carestream Health
Radiology · 166d
Cleared Mar 10, 2026
Sonosite iLOOK Ultrasound System
K260595 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 15d
Cleared Mar 10, 2026
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
K253584 · OWB
Canon Medical Systems Corporation
Radiology · 113d
Cleared Mar 10, 2026
myray ProXIma X6
K252353 · OAS
Cefla S.C.
Radiology · 224d
Cleared Mar 09, 2026
LiverMultiScan (v6.0)
K253413 · LNH
Perspectum, Ltd.
Radiology · 159d
Cleared Mar 06, 2026
Bunkerhill Contrast AVC
K260167 · JAK
BunkerHill Health
Radiology · 45d
Cleared Mar 06, 2026
Bunkerhill Contrast CAC
K260166 · JAK
BunkerHill Health
Radiology · 45d
Cleared Mar 06, 2026
VELYS™ Hip Navigation
K253551 · QIH
Depuy Ireland UC
Radiology · 112d
Cleared Mar 05, 2026
AV Cardiac CT
K260169 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 44d
Cleared Mar 05, 2026
CEPHX3D
K252538 · QIH
Orca Dental AI , Ltd.
Radiology · 205d
Cleared Mar 05, 2026
Magnifico Open (100009900)
K251901 · LNH
Esaote, S.P.A.
Radiology · 258d
Cleared Mar 04, 2026
QT Scanner 2000 Model A
K253898 · IYO
QT Imaging Holdings, Inc.
Radiology · 89d
Cleared Mar 03, 2026
Annalise Enterprise
K253818 · QAS
Harrison-AI Medical Pty, Ltd.
Radiology · 95d
Cleared Mar 03, 2026
SOTA Cloud Smart Sensor (1.5)
K251793 · MUH
Sota Cloud Corp.
Radiology · 265d
Cleared Mar 02, 2026
Clarius Ejection Fraction AI
K253593 · QIH
Clarius Mobile Health Corp.
Radiology · 105d
Cleared Feb 27, 2026
Ligence Heart
K253535 · QIH
Ligence Uab
Radiology · 106d
Cleared Feb 26, 2026
BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax
K253578 · QAS
Aidoc Medical , Ltd.
Radiology · 101d