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
217–240 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 21, 2026
uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite,...
K253720 · IYN
Wuhan United Imaging Healthcare Co.,Ltd
Radiology · 178d
Cleared May 20, 2026
Derma-2
K253911 · LHQ
Neko Health AB
Radiology · 163d
Cleared May 20, 2026
Aquilion ONE (TSX-308A/TSX-306A) V2.0
K253596 · JAK
Canon Medical Systems Corporation
Radiology · 183d
Cleared May 20, 2026
MAASTRO Rectal Applicator Set
K252717 · JAQ
Varian Medical Systems
Radiology · 265d
Cleared May 18, 2026
CMN Capillary Function with Virtual Expert for MRI, CT and CBCT
K253831 · LLZ
Cercare Medical A/S
Radiology · 168d
Cleared May 15, 2026
UNiD™ Spine Analyzer (SW3002)
K261289 · QIH
Medicrea International S.A.S....
Radiology · 25d
Cleared May 15, 2026
Neurophet AQUA
K261273 · QIH
Neurophet., Inc.
Radiology · 28d
Cleared May 15, 2026
SubtleHD-CT (1.x)
K254120 · QIH
Subtle Medical, Inc.
Radiology · 147d
Cleared May 15, 2026
Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior,...
K254028 · IYN
Sonoscape Medical Corp.
Radiology · 150d
Cleared May 15, 2026
medXion NEXUS
K253935 · OAS
medXion Technologies, Inc.
Radiology · 157d
Cleared May 15, 2026
uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE...
K253716 · IYN
Wuhan United Imaging Healthcare Co.,Ltd
Radiology · 172d
Cleared May 15, 2026
Neurophet SCALE PET
K252563 · QIH
Neurophet., Inc.
Radiology · 274d
Cleared May 14, 2026
BriefCase-Triage
K261317 · QAS
Aidoc Medical , Ltd.
Radiology · 23d
Cleared May 14, 2026
Palmtop Ultrasound Diagnostic System (MT10P/MT10)
K260111 · IYN
Mytech Intelligence (Shenzhen) Co., Ltd.
Radiology · 120d
Cleared May 14, 2026
RAYMO Mobile X-ray System (Model: RAYMO)
K260085 · IZL
DRGEM Corporation
Radiology · 122d
Cleared May 14, 2026
SubtleHD-PET (1.x)
K254013 · LLZ
Subtle Medical, Inc.
Radiology · 150d
Cleared May 14, 2026
ART.1-US
K253078 · MUJ
Seetreat Pty, Ltd.
Radiology · 233d
Cleared May 13, 2026
Morph
K260032 · QIH
BeauBrain Healthcare, Inc.
Radiology · 127d
Cleared May 12, 2026
Rayvolve
K260378 · QBS
AZmed
Radiology · 96d
Cleared May 11, 2026
Diagnostic Ultrasound System (MU9)
K260846 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 56d
Cleared May 11, 2026
Velmeni for Dentists (V4D) Endo-Perio
K252953 · MYN
Velmeni, Inc.
Radiology · 237d
Cleared May 08, 2026
AerFrame Patient Immobilization System (AFPIS)
K260792 · IYE
Stabilix, LLC
Radiology · 58d
Cleared May 08, 2026
HipGuide (V 1.0.0.0)
K260321 · LLZ
Orthopedic Driven Imaging, LLC
Radiology · 98d
Cleared May 05, 2026
Healium Intelliscan LX192LC
K261132 · IYN
Healium Intelliscan Corporation
Radiology · 29d