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
649–672 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 17, 2025
Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990,...
K243880 · IYO
Wuxi Hisky Medical Technologies Co.,...
Radiology · 181d
Cleared Jun 17, 2025
uOmniscan
K243666 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 202d
Cleared Jun 16, 2025
Methinks NCCT Stroke
K250685 · QAS
Methinks Software, S.L
Radiology · 102d
Cleared Jun 16, 2025
MAGNETOM Avanto Fit
K250443 · LNH
Siemens Healthcare GmbH
Radiology · 122d
Cleared Jun 16, 2025
MAGNETOM Flow.Ace
K250436 · LNH
Siemens Shenzhen Magnetic Resonance ,...
Radiology · 122d
Cleared Jun 16, 2025
Mosaic (V1.0.1)
K244012 · LLZ
Navier Medical
Radiology · 172d
Cleared Jun 13, 2025
Accuro® 3S Needle Guide Kit
K250469 · ITX
Rivanna Medical, Inc.
Radiology · 115d
Cleared Jun 13, 2025
Brainlab Elements (7.0)
K243633 · QIH
Brainlab AG
Radiology · 200d
Cleared Jun 12, 2025
Aurora
K251153 · KPS
Ge Medical Systems Israel
Radiology · 59d
Cleared Jun 12, 2025
Second Opinion® CS
K243234 · MYN
Pearl, Inc.
Radiology · 245d
Cleared Jun 10, 2025
Viz Subdural+, Viz SUBDURAL PLUS
K250354 · QIH
Viz. Ai, Inc.
Radiology · 123d
Cleared Jun 10, 2025
EXTRON 3
K250010 · OWB
DRTECH Corporation
Radiology · 159d
Cleared Jun 06, 2025
Cirrus Resting State fMRI Software
K251009 · QIH
Sora Neuroscience, Inc.
Radiology · 66d
Cleared Jun 05, 2025
BrightHeart View Classifier
K251456 · QIH
Brightheart
Radiology · 24d
Cleared Jun 05, 2025
UroNav 4
K250800 · LLZ
Philips DS North America, LLC
Radiology · 83d
Cleared Jun 05, 2025
TechLive
K243703 · LLZ
DeepHealth, Inc.
Radiology · 188d
Cleared Jun 05, 2025
Sonic DL
K243667 · LNH
Ge Medical Systems, LLC
Radiology · 190d
Cleared Jun 04, 2025
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and...
K251397 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 29d
Cleared Jun 04, 2025
TraumaCad Neo (1.1)
K243810 · QIH
Brainlab , Ltd.
Radiology · 175d
Cleared May 30, 2025
BriefCase-Triage
K251406 · QAS
Aidoc Medical , Ltd.
Radiology · 24d
Cleared May 30, 2025
Swoop® Portable MR Imaging® System (V2)
K250236 · LNH
Hyperfine, Inc.
Radiology · 123d
Cleared May 30, 2025
TE Air Diagnostic Ultrasound System
K250024 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 144d
Cleared May 30, 2025
Opulus™ Lymphoma Precision
K243863 · QIH
Roche Molecular Systems, Inc.
Radiology · 164d
Cleared May 30, 2025
AudaxCeph Cephalogram Analysis Software
K243005 · QIH
Audax D.O.O.
Radiology · 246d