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MINDWAYS SOFTWARE INC

QCT Pro · General and Plastic Surgery

510(k): 2 Recall: 0 UDI: 9 MAUDE: 1 Class.: 0

510(k) Clearances (2)

2014-08-29

Substantially Equivalent

2001-12-04

Substantially Equivalent

UDI Registrations (9)

QCT Pro Asynchronous Calibration Module, CliniQCT

The QCT Pro Asynchronous Calibration Module is intended to provide an alternative method for calibrating QCT data sets that are intended for analysis with QCT Pro Spine and Hip application modules. Installation of the QCT Pro Asynchronous Calibration Module does not alter the clinical indications for use of the QCT Pro Spine and Hip application modules. It does, however, provide an additional mean…

QCT PRO 3D Volumetric Spine and CTXA Hip System

Convenience Kit consisting of - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database - Model 3 QA & Calibration Phantom Set

QCT PRO 3D Volumetric Spine System

Convenience Kit consisting of - QCT Bone Mineral Density Analysis Software, - Model 3 QA & Calibration Phantom Set and - Accessories.

QCT PRO Asynchronous 3D Spine and CTXA-Hip System

Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database - Model 4 Calibration Phantom

QCT PRO Asynchronous 3D Spine and CTXA-Hip Software

Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database

QCT PRO Asynchronous 3D Spine and CTXA-Hip System

Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database - Model 3 QA & Calibration Phantom Set

QCT PRO 3D Volumetric Spine and CTXA Hip Software

Convenience Kit consisting of - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database

QCT PRO Asynchronous 3D Spine Software

Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Mineral Density Analysis Software - Accessories

QCT PRO 3D Volumetric Spine Software

Convenience Kit consisting of - QCT Bone Mineral Density Analysis Software - Accessories

MAUDE Adverse Events (1)

Injury
20120305