FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
169–192 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 06, 2026
Ricoh 3D for Healthcare Bolus
K253025 · IXI
Ricoh 3D For Healthcare, LLC
Radiology · 199d
Cleared Apr 03, 2026
uMI Panvivo (uMI Panvivo LS)
K260524 · KPS
Shanghai United Imaging Healthcare...
Radiology · 45d
Cleared Apr 03, 2026
ClearCheck (RADCC V2.7)
K253962 · IYE
Radformation, Inc.
Radiology · 113d
Cleared Apr 02, 2026
Wireless Probe Type Ultrasound Scanner
K252709 · IYN
Xuzhou Yongkang Electronic Science...
Radiology · 218d
Cleared Apr 02, 2026
BELLIGER ACE
K252229 · OWB
Genoray Co., Ltd.
Radiology · 260d
Cleared Apr 01, 2026
CoLumbo C-Spine
K254015 · QIH
Smart Soft Healthcare AD
Radiology · 107d
Cleared Apr 01, 2026
Medical Imaging Calibration Feature (MICF)
K253582 · SHN
Apple, Inc.
Radiology · 135d
Cleared Apr 01, 2026
GEM Flex Coil 16-L Array, 3.0T Receive Only
K252876 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 203d
Cleared Mar 27, 2026
S-scan Open (100001800)
K260746 · LNH
Esaote, S.P.A.
Radiology · 21d
Cleared Mar 27, 2026
Automated Aortic Stenosis Software (AutoAS)
K254161 · POK
GE Medical Systems Ultrasound &...
Radiology · 95d
Cleared Mar 27, 2026
EVO Q30 Diagnostic Ultrasound System
K254099 · IYN
Samsung Medison Co., Ltd.
Radiology · 98d
Cleared Mar 27, 2026
Spectral CT Verida Family
K253649 · JAK
Philips Medical Systems Technologies...
Radiology · 127d
Cleared Mar 27, 2026
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction...
K253625 · LNH
Canon Medical Systems Corporation
Radiology · 129d
Cleared Mar 27, 2026
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic...
K253595 · IYN
Philips Ultrasound, LLC
Radiology · 129d
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