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
289–312 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 27, 2026
Contour ProtégéAI+
K253270 · QKB
Mim Software, Inc.
Radiology · 179d
Cleared Mar 27, 2026
ARTICOR planner
K252195 · LLZ
Artiness S.R.L
Radiology · 256d
Cleared Mar 27, 2026
Butterfly Gestational Age Tool
K252148 · IYN
Butterfly Network, Inc.
Radiology · 261d
Cleared Mar 26, 2026
Lunit INSIGHT DBT (V1.2)
K253796 · QDQ
Lunit, Inc.
Radiology · 118d
Cleared Mar 26, 2026
SwiftMR
K253775 · QIH
Airs Medical, Inc.
Radiology · 120d
Cleared Mar 25, 2026
S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
K253406 · LHN
Mevion Medical Systems, Inc.
Radiology · 176d
Cleared Mar 24, 2026
LOGIQ Vita
K260673 · IYN
GE Medical Systems Ultrasound and...
Radiology · 22d
Cleared Mar 24, 2026
Senographe Pristina
K260087 · MUE
GE Medical Systems SCS
Radiology · 71d
Cleared Mar 24, 2026
JLK-NCCT
K252421 · QAS
JLK, Inc.
Radiology · 235d
Cleared Mar 24, 2026
Trinias
K252099 · OWB
Shimadzu Corporation
Radiology · 264d
Cleared Mar 23, 2026
True Definition DL
K253686 · JAK
Ge Healthcare Japan Corporation
Radiology · 122d
Cleared Mar 23, 2026
CT Rembra RT
K252992 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 186d
Cleared Mar 20, 2026
Smart Fit TorsoCardiac 1.5T
K260519 · MOS
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 31d
Cleared Mar 20, 2026
NOMAD Pro 3
K253864 · EHD
Dental Imaging Technologies Corporation
Radiology · 107d
Cleared Mar 20, 2026
SOMATOM X.cite
K253574 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 123d
Cleared Mar 20, 2026
Photonova Spectra, Photonova Spectra Select
K253520 · JAK
Ge Medical Systems, LLC
Radiology · 128d
Cleared Mar 20, 2026
nordicAudio (1.0)
K251937 · LNH
Nordicneurolab AS
Radiology · 269d
Cleared Mar 19, 2026
AutoContour (RADAC V5)
K260509 · QKB
Radformation, Inc.
Radiology · 30d
Cleared Mar 18, 2026
AlignRT Plus (8.0)
K253012 · IYE
Vision Rt, Ltd.
Radiology · 180d
Cleared Mar 18, 2026
syngo.via RT Image Suite VC10
K252304 · MUJ
Varian Medical Systems, Inc.
Radiology · 237d
Cleared Mar 17, 2026
EchoNavigator R5.0
K253614 · QIH
Philips Medical Systems Nederland B.V.
Radiology · 119d
Cleared Mar 16, 2026
Data Analysis Facilitation Suite (DAFS)
K253944 · QIH
Voronoi Health Analytics Incorporated
Radiology · 96d
Cleared Mar 16, 2026
Sonio Detect (v3)
K252433 · IYN
Sonio
Radiology · 227d
Cleared Mar 13, 2026
TheraSphere 360™ Y-90 Management Platform
K260479 · LLZ
Boston Scientific Corporation
Radiology · 28d