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
913–936 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 21, 2024
SKR 3000
K241319 · MQB
Konica Minolta, Inc.
Radiology · 195d
Cleared Nov 20, 2024
Strain AI (SAI001)
K242359 · QIH
Exo, Inc.
Radiology · 103d
Cleared Nov 19, 2024
XENOVIEW 3.0T Chest Coil
K243316 · MOS
Polarean, Inc.
Radiology · 28d
Cleared Nov 19, 2024
“BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)
K243045 · JAQ
Braxx Biotech Co., Ltd.
Radiology · 53d
Cleared Nov 19, 2024
ACUSON Sequoia Diagnostic Ultrasound System
K242523 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Nov 19, 2024
Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)
K242496 · IYO
Eieling Technology (Shenzhen) Limited
Radiology · 89d
Cleared Nov 18, 2024
CT Collaboration Live
K242329 · LLZ
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 104d
Cleared Nov 18, 2024
Saige-Dx
K241747 · QDQ
DeepHealth, Inc.
Radiology · 153d
Cleared Nov 15, 2024
ACUSON Redwood Diagnostic Ultrasound System
K243299 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Nov 15, 2024
The 5000 Compact Series Ultrasound Systems
K242800 · IYN
Philips Ultrasound, LLC
Radiology · 59d
Cleared Nov 15, 2024
Koios DS
K242130 · POK
Koios Medical, Inc.
Radiology · 116d
Cleared Nov 15, 2024
1CMR Pro
K242062 · LLZ
Mycardium AI Limited
Radiology · 123d
Cleared Nov 15, 2024
VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage
K241439 · QFM
Vuno, Inc.
Radiology · 178d
Cleared Nov 15, 2024
VIVIX-S 1751S
K241125 · MQB
Vieworks Co., Ltd.
Radiology · 206d
Cleared Nov 14, 2024
Fetal EchoScan
K242342 · POK
Brightheart
Radiology · 99d
Cleared Nov 12, 2024
Change Healthcare Stratus Imaging PACS
K241981 · LLZ
Change Healthcare Canada Company
Radiology · 130d
Cleared Nov 12, 2024
PRORAD X-Ray Flat Panel Detector with DROC
K240771 · MQB
Prognosys Medical Systems Private...
Radiology · 236d
Cleared Nov 08, 2024
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona...
K242231 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 101d
Cleared Nov 08, 2024
Hybrid Viewer (00859873006189)
K241364 · KPS
Hermes Medical Solutions AB
Radiology · 178d
Cleared Nov 08, 2024
ProFound Detection (V4.0)
K240417 · QDQ
Icad, Inc.
Radiology · 269d
Cleared Nov 07, 2024
Titanium Fletcher-Style Applicator Set Defined Geometry
K241853 · JAQ
Varian Medical Systems, Inc.
Radiology · 133d
Cleared Nov 07, 2024
NeuroICH
K241719 · QAS
Neurocareai, Inc.
Radiology · 146d
Cleared Nov 07, 2024
IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)
K241346 · MQB
Aspen Imaging Healthcare, Inc.
Radiology · 178d
Cleared Nov 07, 2024
icobrain aria
K240712 · QBS
Icometrix NV
Radiology · 237d