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
505–528 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 01, 2025
Shear Wave Quantificational Ultrasound Diagnostic System...
K250026 · IYN
Wuxi Hisky Medical Technologies Co.,...
Radiology · 268d
Cleared Sep 30, 2025
Astrasono A3Pro Bladder Scanner (A3Pro)
K250331 · IYO
Astrasono Technology Co., Ltd.
Radiology · 237d
Cleared Sep 29, 2025
SMART PCFD
K250023 · QIH
Disior, Ltd.
Radiology · 269d
Cleared Sep 26, 2025
Ligence Heart
K252105 · QIH
Ligence Uab
Radiology · 85d
Cleared Sep 26, 2025
Self-Propelled CT Scan Base Kit, CGBA-035A
K251645 · JAK
Canon Medical Systems Corporation
Radiology · 120d
Cleared Sep 26, 2025
Planmed XFI
K250318 · SFV
Planmed OY
Radiology · 234d
Cleared Sep 25, 2025
uMR 680
K252371 · LNH
Shanghai United Imaging Healthcare...
Radiology · 57d
Cleared Sep 25, 2025
Brain WMH
K251527 · QIH
Quantib B.V.
Radiology · 129d
Cleared Sep 24, 2025
Digital X-Ray DentiMax Pro Imaging System
K251206 · MUH
Dentimax, Inc.
Radiology · 159d
Cleared Sep 24, 2025
uWS-Angio Pro
K250045 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 257d
Cleared Sep 23, 2025
Rapid Aortic Measurements
K251987 · QIH
Ischemaview, Inc.
Radiology · 88d
Cleared Sep 23, 2025
SwiftSight-Brain
K251483 · QIH
Airs Medical, Inc.
Radiology · 132d
Cleared Sep 19, 2025
uDR Aurora CX
K251167 · KPR
Shanghai United Imaging Healthcare...
Radiology · 157d
Cleared Sep 19, 2025
Videa Dental AI
K251002 · MYN
Videahealth, Inc.
Radiology · 171d
Cleared Sep 18, 2025
ULTRASONIC PROBE UM-3R (UM-3R)
K250883 · ITX
Olympus Medical Systems Corporation
Radiology · 178d
Cleared Sep 18, 2025
Axial3D Insight
K250369 · QIH
Axial Medical Printing Limited
Radiology · 220d
Cleared Sep 17, 2025
ECHELON Synergy
K251386 · LNH
Fujifilm Corporation
Radiology · 135d
Cleared Sep 16, 2025
Insight Enhanced™ DRF (EN-1002-01)
K251650 · JAA
Imaging Engineering, LLC
Radiology · 110d
Cleared Sep 15, 2025
InferOperate Suite
K250237 · QIH
Beijing Infervision Healthcare...
Radiology · 231d
Cleared Sep 12, 2025
ViewMateTM Ultrasound System
K251820 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 91d
Cleared Sep 12, 2025
FETOLY
K251368 · IYN
Diagnoly
Radiology · 134d
Cleared Sep 12, 2025
S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
K250986 · LHN
Mevion Medical Systems, Inc.
Radiology · 165d
Cleared Sep 12, 2025
uWS-Angio
K250040 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 247d
Cleared Sep 12, 2025
BONX805
K243864 · IZL
Bontech Co., Ltd.
Radiology · 269d