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
241–264 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 05, 2026
Lumify Diagnostic Ultrasound System
K252558 · IYN
Philips Ultrasound, LLC
Radiology · 265d
Cleared May 04, 2026
Neowise
K260716 · LLZ
Cefla S.C.
Radiology · 60d
Cleared May 04, 2026
MammoSightAI
K252954 · QFM
Neurocareai, Inc. (Dba Savelife.Ai)
Radiology · 230d
Cleared Apr 30, 2026
Synapse 3D Base Tools (V7.2)
K254189 · QIH
Fujifilm Corporation
Radiology · 128d
Cleared Apr 30, 2026
Intelligent NR
K252503 · OWB
Canon, Inc.
Radiology · 265d
Cleared Apr 29, 2026
ES-Series
K260589 · IYN
E-Scopics
Radiology · 68d
Cleared Apr 29, 2026
syngo Application Software
K254184 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 127d
Cleared Apr 29, 2026
DeepHealth ProstateAI
K253682 · QDQ
Quantib B.V.
Radiology · 159d
Cleared Apr 24, 2026
LungPoint Virtual Bronchoscopic Navigation (VBN) Software
K260009 · LLZ
Broncus Medical, Inc.
Radiology · 112d
Cleared Apr 24, 2026
ARTIS icono floor
K254173 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 122d
Cleared Apr 24, 2026
EdgeFlow Gel Pad
K252337 · MUI
Edgecare, Inc.
Radiology · 270d
Cleared Apr 23, 2026
0.55T 12Ch Breast Coil
K260947 · MOS
Neocoil, LLC
Radiology · 31d
Cleared Apr 23, 2026
DS Core CBCT Anatomy
K260785 · QIH
Dentsply Sirona
Radiology · 44d
Cleared Apr 23, 2026
Lunit INSIGHT MMG (v1.1.10)
K260320 · QDQ
Lunit, Inc.
Radiology · 83d
Cleared Apr 23, 2026
CCI PACS VIEWER (PACS-US-001)
K254237 · LLZ
CliniComp, Intl.
Radiology · 115d
Cleared Apr 23, 2026
ARTIS genio floor
K253752 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 149d
Cleared Apr 23, 2026
ProBeam 360 Proton Therapy System v3.0
K252815 · LHN
Varian Medical Systems, Inc.
Radiology · 231d
Cleared Apr 22, 2026
EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)
K253163 · QAS
Ever Fortune.Ai, Co., Ltd.
Radiology · 208d
Cleared Apr 22, 2026
uOmnispace.MR
K253077 · QIH
Shanghai United Imaging Healthcare...
Radiology · 211d
Cleared Apr 20, 2026
Lunar Astra
K252718 · KGI
GE Medical Systems Ultrasound &...
Radiology · 235d
Cleared Apr 20, 2026
Folliscan
K252332 · QIH
Mim Fertility
Radiology · 269d
Cleared Apr 17, 2026
EdgeFlow UW20
K252237 · IYO
Edgecare, Inc.
Radiology · 274d
Cleared Apr 15, 2026
VERIQA RT EPID 3D
K252258 · IYE
Ptw-Freiburg...
Radiology · 268d
Cleared Apr 14, 2026
Critical Care Suite with Enteric Tube Positioning AI Algorithm
K253502 · QIH
Ge Medical Systems, LLC
Radiology · 166d