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
817–840 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Nov 05, 2024
TeraRecon Cardiac.Chambers.MR (1.0.0)
K241312 · QIH
Terarecon,Inc.
Radiology · 180d
Cleared Nov 04, 2024
JLK-PWI
K242709 · LLZ
JLK, Inc.
Radiology · 56d
Cleared Nov 01, 2024
XERO-alpha
K242591 · EHD
DRTECH Corporation
Radiology · 63d
Cleared Nov 01, 2024
uDR 780i
K241068 · KPR
Shanghai United Imaging Healthcare...
Radiology · 196d
Cleared Oct 31, 2024
eRAD PACS
K241223 · LLZ
Erad, Inc.
Radiology · 183d
Cleared Oct 30, 2024
Symbia Pro.specta Q3 (11364751)
K243186 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Oct 30, 2024
RemedyLogic AI MRI Lumbar Spine Reader
K241108 · QIH
Remedy Logic, Inc.
Radiology · 191d