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
121–144 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 28, 2026
V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound...
K261412 · IYN
Samsung Medison Co., Ltd.
Radiology · 89d
Cleared Jul 28, 2026
See-Mode Augmented Reporting Tool, Breast (SMART-B)
K260303 · QDQ
See-Mode Technologies Pty, Ltd.
Radiology · 179d
Cleared Jul 28, 2026
BodyTom Elite (NL4000)
K253450 · JAK
NeuroLogica Corp., a Samsung Company
Radiology · 299d
Cleared Jul 27, 2026
ND Needle Guidance System
K262474 · ITX
Accurate Access, LLC
Radiology · 10d
Cleared Jul 27, 2026
Philips EPIQ Series Diagnostic Ultrasound System
K261211 · IYN
Philips Ultrasound, LLC
Radiology · 104d
Cleared Jul 24, 2026
TheraSphere 360™ Y-90 Management Platform
K262462 · LLZ
Boston Scientific Corporation
Radiology · 7d
Cleared Jul 24, 2026
LumenCare Azure
K262383 · JAQ
Nucletron B.V.
Radiology · 11d
Cleared Jul 24, 2026
dS FootAnkle 16Ch 1.5T
K262294 · MOS
Philips Medical Systems Nederland B.V.
Radiology · 17d
Cleared Jul 24, 2026
SwiftMR
K261349 · QIH
Airs Medical, Inc.
Radiology · 91d
Cleared Jul 24, 2026
Accuro® 3S Needle Guide Kit
K261014 · ITX
Rivanna Medical, Inc.
Radiology · 119d
Cleared Jul 24, 2026
DIANA
K260192 · QIH
ROPCA ApS
Radiology · 183d
Cleared Jul 24, 2026
Accuro 3S
K253452 · IYO
Rivanna Medical, Inc.
Radiology · 291d
Cleared Jul 23, 2026
ImageGrid StreamVue
K262143 · LLZ
Candelis, Inc.
Radiology · 28d
Cleared Jul 23, 2026
Dental Cone-beam Computed Tomography (mDX-15P Series)
K261748 · OAS
Hefei Meyer Optoelectronic...
Radiology · 56d
Cleared Jul 23, 2026
ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/...
K261272 · IYN
Esonic Technology (Wuhan) Co., Ltd.
Radiology · 97d
Cleared Jul 23, 2026
Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)
K261081 · IYN
Beijing Konted Medical Technology...
Radiology · 113d
Cleared Jul 23, 2026
VELMENI for DENTISTS (V4D) 3D
K254096 · QIH
Velmeni, Inc.
Radiology · 216d
Cleared Jul 21, 2026
ResolutionMD
K260500 · LLZ
ResolutionMD, Inc.
Radiology · 158d
Cleared Jul 21, 2026
CardIQ Suite
K253770 · JAK
GE Medical Systems SCS
Radiology · 237d
Cleared Jul 20, 2026
Hi-D Imaging 4TAVR
K261535 · QIH
Hi-D Imaging AG
Radiology · 73d
Cleared Jul 17, 2026
Cubresa BrainPET
K253963 · OUO
Cubresa, Inc.
Radiology · 218d
Cleared Jul 15, 2026
Better Diagnostics Dental Assist (BDDA) Version 1.0
K260851 · MYN
Better Diagnostics AI Corp.
Radiology · 121d
Cleared CT Jul 15, 2026
ThinkSono Guidance
K260338 · QJU
ThinkSono GmbH
Radiology · 163d
Cleared Jul 15, 2026
SkeletonPlanner
K260206 · QIH
UPlanner B.V. - Presurgeo
Radiology · 173d