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
2281–2304 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 27, 2021
Insight Agile DRF
K210469 · JAA
Imaging Engineering, LLC
Radiology · 161d
Cleared Jul 23, 2021
MySpine WebPlanner & MyBalance
K211386 · LLZ
Medacta International S.A.
Radiology · 79d
Cleared Jul 23, 2021
SC1 Handheld Ultrasound Imaging System (Model: SC1)
K210468 · IYO
Fcu Co., Ltd.
Radiology · 157d
Cleared Jul 22, 2021
ExacTrac Dynamic
K211939 · IYE
Brainlab AG
Radiology · 29d
Cleared Jul 22, 2021
DC-Air and Athlos-1 and Athlos-Air
K211688 · MUH
Athlos OY
Radiology · 50d
Cleared Jul 22, 2021
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit...
K211633 · LNH
Canon Medical Systems Corporation
Radiology · 56d
Cleared Jul 22, 2021
QSM software, QSMetric
K210415 · LNH
Medimagemetric, LLC
Radiology · 161d
Cleared Jul 22, 2021
syngo.CT Skull Unfolding
K203411 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 245d
Cleared Jul 20, 2021
ACUSON Sequoia Diagnostic Ultrasound System
K211859 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 34d
Cleared Jul 20, 2021
Change Healthcare Anatomical AI
K210719 · QIH
Change Healthcare Canada Company
Radiology · 132d
Cleared Jul 20, 2021
Chest-CAD
K210666 · MYN
Imagen Technologies, Inc.
Radiology · 137d
Cleared Jul 20, 2021
ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL...
K203765 · LLZ
Zirkonzahn Srl
Radiology · 209d
Cleared Jul 14, 2021
SMART FINDER
K203509 · IZH
Ims Giotto S.P.A.
Radiology · 226d
Cleared Jul 12, 2021
PowerLook Density Assessment V4.0
K211506 · QIH
Icad, Inc.
Radiology · 59d
Cleared Jul 12, 2021
RadiForce RX370
K211491 · PGY
Eizo Corporation
Radiology · 60d
Cleared Jul 09, 2021
PRIMO S
K211542 · MQB
A.T.S. Applicazione Tecnologie...
Radiology · 51d
Cleared Jul 09, 2021
HM70 EVO Diagnostic Ultrasound System
K210713 · IYN
Samsung Medison Co., Ltd.
Radiology · 121d
Cleared Jul 08, 2021
HALO
K211788 · QAS
Nicolab B.V.
Radiology · 29d
Cleared Jul 08, 2021
NubeX
K211480 · LLZ
Techheim Co., Ltd.
Radiology · 57d
Cleared Jul 08, 2021
iSR'obot Mona Lisa 1.0
K203659 · IYO
Biobot Surgical Pte., Ltd.
Radiology · 205d
Cleared Jul 08, 2021
PRE-SURE
K201835 · LLZ
Lazarus 3D, Inc.
Radiology · 371d
Cleared Jul 07, 2021
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
K211818 · LNH
Hyperfine, Inc.
Radiology · 26d
Cleared Jul 07, 2021
ONE Planner Hip
K210653 · LLZ
Orthosoft D/B/A Zimmer Cas
Radiology · 125d
Cleared Jul 01, 2021
ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9
K211782 · OWB
Controlrad, Inc.
Radiology · 22d