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
2425–2448 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 23, 2021
2MP Monochrome LCD Monitor MS-S200
K210345 · PGY
Jvckenwood Corporation
Radiology · 77d
Cleared Apr 23, 2021
PlutoX Digital Intraoral X-Ray Imaging System
K210312 · MUH
Iray Technology Taicang , Ltd.
Radiology · 79d
Cleared Apr 23, 2021
MEDO-Thyroid
K203502 · QIH
Medo DX Pte. , Ltd.
Radiology · 144d
Cleared Apr 23, 2021
Cartesion Prime (PCD-1000A/3) V10.8
K203314 · KPS
Canon Medical Systems Corporation
Radiology · 164d
Cleared Apr 21, 2021
Yushan X-Ray Flat Panel Detector with DROC
K210988 · MQB
Innocare Optoelectronics Corp.
Radiology · 20d
Cleared Apr 21, 2021
Preview Shoulder
K210556 · QIH
Genesis Software Innovations
Radiology · 55d
Cleared Apr 20, 2021
Identify
K210835 · IYE
Varian Medical Systems, Inc.
Radiology · 29d
Cleared Apr 20, 2021
Automatic Anatomy Recognition (AAR)
K203610 · QKB
Quantitative Radiology Solutions, LLC
Radiology · 131d
Cleared Apr 19, 2021
AI Segmentation
K203469 · MUJ
Varian Medical Systems, Inc.
Radiology · 145d
Cleared Apr 16, 2021
Saige-Q
K203517 · QFM
DeepHealth, Inc.
Radiology · 137d
Cleared Apr 16, 2021
rainbow CT
K200271 · OAS
Dentium Co., Ltd (Ict Branch)
Radiology · 437d
Cleared Apr 16, 2021
rainbow MCT
K200270 · OAS
Dentium Co., Ltd (Ict Branch)
Radiology · 437d
Cleared Apr 14, 2021
CX30N (CX30PQX)
K210493 · PGY
Wide Corporation
Radiology · 54d
Cleared Apr 14, 2021
BriefCase, RIB Fractures Triage (RibFx)
K202992 · QFM
Aidoc Medical , Ltd.
Radiology · 196d
Cleared Apr 12, 2021
Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2
K210900 · OWB
Canon Medical Systems Corporation
Radiology · 17d
Cleared Apr 12, 2021
Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software -...
K202679 · KPS
Mcgovern Medical School
Radiology · 209d
Cleared Apr 09, 2021
HYPER Focus
K210418 · KPS
Shanghai United Imaging Healthcare...
Radiology · 57d
Cleared Apr 09, 2021
HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System
K210068 · IYN
Samsung Medison Co., Ltd.
Radiology · 88d
Cleared Apr 09, 2021
RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS,...
K203681 · MUJ
Brainlab AG
Radiology · 113d
Cleared Apr 09, 2021
DeepLook PRECISE
K202084 · LLZ
Deeplook, Inc.
Radiology · 256d
Cleared Apr 08, 2021
CW120N
K210491 · PGY
Wide Corporation
Radiology · 48d
Cleared Apr 08, 2021
Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa...
K202785 · IYN
Shenzhen Mindray Bio-Meidcal...
Radiology · 198d
Cleared Apr 05, 2021
ADAS 3D
K210850 · LLZ
Adas3D Medical S.L.
Radiology · 14d
Cleared Apr 05, 2021
StentBoost Mobile
K203623 · OWB
Philips India Limited
Radiology · 115d