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
1249–1272 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 25, 2024
BreView
K233714 · LLZ
GE Medical Systems SCS
Radiology · 66d
Cleared Jan 24, 2024
Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System
K233195 · IYN
Canon Medical Systems Corporation
Radiology · 118d
Cleared Jan 24, 2024
Axial3D Cloud Segmentation Service
K231607 · LLZ
Axial Medical Printing Limited
Radiology · 237d
Cleared Jan 19, 2024
SIGNA Champion
K233728 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 59d
Cleared Jan 19, 2024
Rapid ASPECTS (v3)
K232156 · POK
Ischemaview, Inc.
Radiology · 183d
Cleared Jan 18, 2024
NemoScan
K232698 · QIH
Software Nemotec S.L.
Radiology · 135d
Cleared Jan 18, 2024
uEXPLORER
K231762 · KPS
Shanghai United Imaging Healthcare...
Radiology · 216d
Cleared Jan 18, 2024
ThinkQA (Edition 2)
K231573 · IYE
Dosisoft SA
Radiology · 232d
Cleared Jan 17, 2024
Clear Guide SCENERGY
K234030 · JAK
Clear Guide Medical
Radiology · 28d
Cleared Jan 17, 2024
FlexView Diagnostic (v1.1.20)
K233226 · LLZ
Radical Imaging, LLC
Radiology · 111d
Cleared Jan 17, 2024
Radify Triage
K231871 · QFM
Envisionit Deepai, Ltd.
Radiology · 205d
Cleared Jan 16, 2024
Rapid (6.0)
K233512 · QIH
Ischemaview, Inc.
Radiology · 76d
Cleared Jan 16, 2024
Delta4 Insight
K223234 · IYE
Scandidos AB
Radiology · 454d
Cleared Jan 12, 2024
Biograph VK10
K233677 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 57d
Cleared Jan 12, 2024
PROBEAT-FR
K232032 · LHN
Hitachi, Ltd. Radiation Oncology...
Radiology · 189d
Cleared Jan 11, 2024
ProxiDiagnost N90 / Precision CRF (706110, 706400)
K233945 · JAA
Philips Medical Systems Dmc GmbH
Radiology · 28d
Cleared Jan 11, 2024
U-Lite PRO
K232285 · IYN
Sonoscanner Sarl
Radiology · 164d
Cleared Jan 09, 2024
Dental Cone-beam Computed Tomography
K232710 · OAS
Yian Medical Technology (Haining)...
Radiology · 126d
Cleared Jan 08, 2024
InkSpace Imaging Small Body Array
K233444 · MOS
Inkspace Imaging, Inc.
Radiology · 81d
Cleared Jan 08, 2024
LungQ v3.0.0
K232412 · JAK
Thirona BV
Radiology · 151d
Cleared Jan 08, 2024
DASI Dimensions (V1.0)
K231324 · QIH
Dasi Simulations
Radiology · 245d
Cleared Jan 05, 2024
VEA Align
K231917 · QIH
Eos Imaging
Radiology · 190d
Cleared Jan 05, 2024
ArcherQA (V1.0)
K231273 · IYE
Wisdom Technologies., Inc.
Radiology · 248d
Cleared Jan 04, 2024
Butterfly iQ3 Ultrasound System
K232808 · IYN
Butterfly Network, Inc.
Radiology · 114d