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
769–792 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Dec 09, 2024
AutoContour (Model RADAC V4)
K242729 · QKB
Radformation, Inc.
Radiology · 90d
Cleared Dec 09, 2024
Digital Radiography System (ManntiX B, ManntiX K)
K240841 · IZL
Shenzhen Browiner Tech Co., Ltd.
Radiology · 257d
Cleared Dec 06, 2024
SyMRI
K242524 · LNH
Syntheticmr AB (Publ.)
Radiology · 105d
Cleared Dec 06, 2024
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert
K241989 · LLZ
Cercare Medical A/S
Radiology · 151d
Cleared Dec 06, 2024
EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)
K241923 · QAS
Ever Fortune.Ai, Co., Ltd.
Radiology · 158d
Cleared Dec 06, 2024
MC2 Portable X-ray System
K241567 · OWB
Oxos Medical
Radiology · 189d
Cleared Dec 06, 2024
DrAid™ for Liver Segmentation
K241543 · QIH
Vinbrain Joint Stock Company
Radiology · 189d