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510(k) K252133

Device
Adaptix Ortho350
Applicant
Adaptix Limited
510(k) number
K252133
Product code
IZF
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-06
Date received
2025-07-07
Regulation
892.1740
Classification name
System, X-Ray, Tomographic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Y

Applicant Contact#

Contact
Martin Stofanko
Address
Centre For Innovation And Enterprise, University Of Oxford Begbroke Science Park, Woodstock Rd. Oxford GB OX5 1PF OX5 1PF

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K252649TAP2DNano-X Imaging , Ltd.2026-02-02
K250850Nanox.ARC XNano-X Imaging , Ltd.2025-04-16
K242395Nanox.ARCNano-X Imaging , Ltd.2024-12-04
K222934Nanox.ARCNano-X Imaging , Ltd.2023-04-28
K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH2023-01-26
K213081CLISIS SYSTEMS, Discovery RF180General Medical Merate S.P.A2021-10-26
K193262DR 600 with TomosynthesisAgfa N.V.2020-03-09
K183275DR 800 with TomosynthesisAgfa N.V.2019-02-01
K132261DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)Ge Medical Systems, LLC2013-11-18
K121499FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEMFujifilm Medical System U.S.A., Inc.2012-11-20
K013620MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTIONMedstone Intl., Inc.2002-01-22
K011290PROGNOST ES, MODEL 0302 0000Xmar Corp.2001-05-30
K973864COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMOPausch Corp.1998-06-17
K973834CS2000 & CS2000 TOMOPausch Corp.1998-04-30
K950571LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270Continental X-Ray Corp.1995-03-31