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 ×
15,695 results
265–288 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 14, 2026
HD 8Ch Wrist Array
K252587 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 242d
Cleared Apr 10, 2026
Overjet Iris Intelligent Imaging System
K253930 · QIH
Overjet, Inc.
Radiology · 122d
Cleared Apr 10, 2026
syngo Dynamics (VA41F)
K253689 · QIH
Siemens Healthcare GmbH
Radiology · 140d
Cleared Apr 10, 2026
AeroDR TX c02
K253446 · KPR
Dk Medical Systems Co., Ltd.
Radiology · 190d
Cleared Apr 10, 2026
AI-Rad Companion Organs RT
K252548 · QKB
Siemens Healthcare GmbH
Radiology · 240d
Cleared Apr 10, 2026
DeepBT Detector-Plus
K252190 · QKB
Aitewan Biomedical Technology, Inc.
Radiology · 270d
Cleared Apr 09, 2026
RCT800
K260462 · OAS
Ray Co., Ltd.
Radiology · 56d
Cleared Apr 09, 2026
Accuro XV
K254021 · IYO
Rivanna Medical, Inc.
Radiology · 114d
Cleared Apr 06, 2026
APERTO Lucent MRI System
K253862 · LNH
Fujifilm Corporation
Radiology · 124d
Cleared Apr 06, 2026
6450 Ultrasound System (MyLabE80)
K253288 · IYN
Esaote, S.P.A.
Radiology · 189d
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 CT 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