Model 3 CT Calibration Phantom

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Device name

Model 4 Phantom

Model / reference

Model 4 Phantom, 13002

Primary DI / UDI-DI

+B052PHCTM30

Basic UDI-DI

++B052PHANTOMTU

EMDN code

Z11900180 Bone densitometry systems - hardware accessories

Device class

Class I

EU registration type

Standard device

EU market of registration

France

EUDAMED SRN

US-MF-000012877

Authorised representative

Johner Medical GmbH DE-AR-000011832

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• QCT PRO 3D Volumetric Spine Software K894854

  Class II

  FDA 510(k) ×3 Active Cleared 4 Dec 2001 GUDID on market

• CTXA Hip Bone Mineral Densitometer K002113

  Class II

  FDA 510(k) K002113 Active Cleared 4 Dec 2001 GUDID on market

• QCT Bone Mineral Density Analysis Software K894854

  Class II

  FDA 510(k) K894854 Active Cleared 19 Oct 1989 GUDID on market

• Model 4 CT Calibration Phantom

  Class II

  FDA 510(k) ×4 Active Cleared 4 Dec 2001 GUDID on market

See all devices from Mindways Software, Inc. →