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
1009–1032 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 06, 2024
uAI Portal
K240411 · QIH
Shanghai United Imaging Intelligence...
Radiology · 207d
Cleared Sep 06, 2024
T2 Plus
K233806 · OAS
Osstem Implant Co., Ltd.
Radiology · 282d
Cleared Sep 05, 2024
TRAQinform IQ
K233998 · LLZ
Aiq Global, Inc.
Radiology · 262d
Cleared Sep 04, 2024
Velacur
K233977 · IYO
Sonic Incytes
Radiology · 261d
Cleared Sep 03, 2024
SOMATOM On.site
K241295 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 118d
Cleared Aug 30, 2024
MI View&GO
K242300 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Aug 30, 2024
syngo.via MI Workflows
K242275 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Aug 30, 2024
Imbio PHA (4.0.0)
K241847 · QIH
Imbio, Inc.
Radiology · 65d
Cleared Aug 30, 2024
Ultrasound Transducer Cover
K241662 · ITX
Vitrolife Sweden AB
Radiology · 81d
Cleared Aug 30, 2024
uMI Panorama
K241585 · KPS
Shanghai United Imaging Healthcare...
Radiology · 88d
Cleared Aug 30, 2024
Heyman Packing Applicator Set (GM11004580)
K241386 · JAQ
Varian Medical Systems, Inc.
Radiology · 107d
Cleared Aug 30, 2024
Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)
K241318 · MUJ
Adaptiiv Medical Technologies, Inc.
Radiology · 112d
Cleared Aug 30, 2024
Vave Wireless Ultrasound System
K241051 · IYN
Vave Health, Inc.
Radiology · 135d
Cleared Aug 30, 2024
Velmeni for Dentists (V4D)
K240003 · MYN
Velmeni, Inc.
Radiology · 241d
Cleared Aug 30, 2024
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5
K233107 · OWB
Canon Medical Systems Corporation
Radiology · 338d
Cleared CT Aug 29, 2024
Kosmos
K233826 · IYN
EchoNous, Inc.
Radiology · 272d
Cleared Aug 27, 2024
Overjet Charting Assist
K241684 · QIH
Overjet, Inc.
Radiology · 77d
Cleared Aug 26, 2024
MyoStrain (6.0)
K241607 · LNH
Myocardial Solutions, Inc.
Radiology · 83d
Cleared Aug 23, 2024
SonoSync
K241302 · LLZ
Samsung Medison Co., Ltd.
Radiology · 106d
Cleared Aug 22, 2024
Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)
K241979 · IYN
Beijing Konted Medical Technology...
Radiology · 48d
Cleared Aug 22, 2024
NeuroQuant
K241098 · QIH
Cortechs Labs, Inc.
Radiology · 122d
Cleared Aug 21, 2024
AiMIFY (1.x)
K240290 · LLZ
Subtle Medical, Inc.
Radiology · 202d
Cleared Aug 20, 2024
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit...
K241496 · LNH
Canon Medical Systems Corporation
Radiology · 84d
Cleared Aug 19, 2024
HealthCCSng
K241440 · JAK
Nano-X AI , Ltd.
Radiology · 90d