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
865–888 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 23, 2024
Adora DRFi (04550010)
K242948 · JAA
Nrt X-Ray A/S
Radiology · 89d
Cleared Dec 23, 2024
NIDO Baby Magnetic Resonance Imaging System
K242573 · LNH
Jiangsu Lici Medical Device Co., Ltd.
Radiology · 116d
Cleared Dec 23, 2024
Aquilion ONE (TSX-308A/3) V1.5
K242403 · JAK
Canon Medical Systems Corporation
Radiology · 132d
Cleared Dec 20, 2024
InkSpace Imaging Small Body Array
K243675 · MOS
Inkspace Imaging, Inc.
Radiology · 23d
Cleared Dec 20, 2024
aprevo® Digital Planning
K242599 · LLZ
Carlsmed, Inc.
Radiology · 112d
Cleared Dec 20, 2024
Lightning Viewer
K242362 · LLZ
Nexsys Electronics Inc. Dba Medweb
Radiology · 133d
Cleared Dec 20, 2024
Voluson Expert 18
K242168 · IYN
GE Medical Systems Ultrasound and...
Radiology · 149d
Cleared Dec 19, 2024
Saige-Density (2.5.0)
K243705 · QIH
DeepHealth, Inc.
Radiology · 20d
Cleared Dec 19, 2024
Saige-Dx (3.1.0)
K243688 · QDQ
DeepHealth, Inc.
Radiology · 20d
Cleared Dec 19, 2024
Yushan X-Ray Flat Panel Detector
K243171 · MQB
Innocare Optoelectronics Corp.
Radiology · 80d
Cleared Dec 19, 2024
IQ-UIP
K242467 · QWO
Imbio, Inc.
Radiology · 121d
Cleared Dec 19, 2024
OrthoNext Platform System
K242270 · QIH
Orthofix Srl
Radiology · 140d
Cleared Dec 16, 2024
TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)
K242015 · IZL
DRGEM Corporation
Radiology · 159d
Cleared Dec 16, 2024
MSKai
K240793 · QIH
Mskai
Radiology · 269d
Cleared Dec 16, 2024
ULTIMUS Series Ultrasound Diagnostic System
K240676 · IYN
Vinno Technology (Suzhou) Co.,Ltd
Radiology · 280d
Cleared Dec 13, 2024
ARIA Radiation Therapy Management System (18.1)
K242463 · MUJ
Varian Medical Systems, Inc.
Radiology · 116d
Cleared Dec 12, 2024
uMI Panvivo (uMI Panvivo)
K243538 · KPS
Shanghai United Imaging Healthcare...
Radiology · 27d
Cleared Dec 12, 2024
EPIQ Series Diagnostic Ultrasound System
K242020 · IYN
Philips Ultrasound, LLC
Radiology · 154d
Cleared Dec 11, 2024
BriefCase-Triage
K243548 · QFM
Aidoc Medical , Ltd.
Radiology · 26d
Cleared Dec 11, 2024
Eclipse Treatment Planning System (18.1)
K242378 · MUJ
Varian Medical Systems
Radiology · 124d
Cleared Dec 10, 2024
Digital Color Doppler Ultrasound Imaging System (Readius L15)
K243132 · IYN
Shantou Institute of Ultrasonic...
Radiology · 71d
Cleared Dec 10, 2024
V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5...
K242511 · IYN
Samsung Medison Co., Ltd.
Radiology · 109d
Cleared Dec 10, 2024
IRISeg
K242461 · QIH
Intuitive Surgical, Inc.
Radiology · 113d
Cleared Dec 10, 2024
DRX-Revolution Mobile X-ray System
K241505 · IZL
Carestream Health, Inc.
Radiology · 196d