FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
937–960 of 15,620
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 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