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 ×
15,695 results
2353–2376 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 27, 2021
Volpara Imaging Software
K211279 · LLZ
Volpara Health Technologies Limited
Radiology · 91d
Cleared Jul 27, 2021
PET VCAR
K211247 · KPS
GE Medical Systems SCS
Radiology · 92d
Cleared Jul 27, 2021
Us2.v1
K210791 · QIH
Eko.Ai Pte Ltd. D/B/A Us2.Ai
Radiology · 133d
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