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
913–936 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Aug 16, 2024
qCT LN Quant
K240740 · QIH
Qure.Ai Technologies
Radiology · 151d
Cleared Aug 15, 2024
uMI Panvivo
K241596 · KPS
Shanghai United Imaging Healthcare...
Radiology · 73d
Cleared Aug 15, 2024
CoLumbo
K241211 · QIH
Smart Soft Healthcare
Radiology · 107d
Cleared Aug 15, 2024
UltraDrape UGPIV Barrier and Securement (34-15)
K233965 · ITX
Parker Laboratories, Inc.
Radiology · 244d
Cleared Aug 13, 2024
ECHELON Synergy MRI System
K241429 · LNH
Fujifilm Healthcare Corporation
Radiology · 84d
Cleared Aug 13, 2024
Bullsai
K241094 · LLZ
Turing Medical Technologies, Inc.
Radiology · 113d
Cleared Aug 12, 2024
dS FootAnkle Coil 8ch 1.5T
K242096 · MOS
Philips Medical Systems Nederland B.V.
Radiology · 25d