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
2353–2376 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jul 01, 2021
decimal Bolus
K211511 · MUJ
.Decimal, LLC
Radiology · 48d
Cleared Jul 01, 2021
DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
K211337 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 59d
Cleared Jul 01, 2021
MAGNETOM Free.Max
K210611 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 122d
Cleared Jun 29, 2021
STAGE
K210843 · LNH
Spintech, Inc.
Radiology · 99d
Cleared Jun 29, 2021
RayStation 10.1
K210645 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 118d
Cleared Jun 29, 2021
12MP Color Digital Mammography LCD Monitor CL-S1200
K203733 · PGY
Jvckenwood Corporation
Radiology · 190d
Cleared Jun 29, 2021
Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20,...
K203645 · IYN
Supersonic Imagine
Radiology · 197d
Cleared Jun 25, 2021
3D Echo v1.1
K211656 · LLZ
Jointvue, LLC
Radiology · 28d