QCT PRO 3D Volumetric Spine System QCTPROM3SS

GUDID B052QCTPROM3SS0

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

MINDWAYS SOFTWARE, INC.

CT system application software

• Primary Device ID: B052QCTPROM3SS0
• NIH Device Record Key: 2d6f166e-9c43-4f8e-8d83-c951e788c0ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QCT PRO 3D Volumetric Spine System
• Version Model Number: K894854
• Catalog Number: QCTPROM3SS
• Company DUNS: 964202592
• Company Name: MINDWAYS SOFTWARE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 512 912-0871
• Email: info@qct.com
• Phone: +1 512 912-0871
• Email: info@qct.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B052QCTPROM3SS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894854

FDA Product Code

• KGI: Densitometer, Bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-31

Devices Manufactured by MINDWAYS SOFTWARE, INC.

• B052PHCTM40 - Model 4 CT Calibration Phantom: 2023-05-12 Calibration phantom intended for use as an accessory to the QCT Pro Bone Mineral Densitometry Software.
• B052DIASYNC0 - QCT Pro Asynchronous Calibration Module, CliniQCT: 2018-07-06 The QCT Pro Asynchronous Calibration Module is intended to provide an alternative method for calibrating QCT data sets that are
• B052DICTXAHIP0 - CTXA Hip Bone Mineral Densitometer: 2018-07-06 The CTXA Hip Bone Mineral Densitometer (CTXA Hip) is a software package intended for estimation of bone mineral content (BMC), i
• B052DICTXAHIPEXTDB0 - CTXA Hip Extended Reference Data: 2018-07-06 The CTXA Hip Extended Reference Data is an accessory to the CTXA Hip Bone Mineral Densitometer. The CTXA Hip Extended Reference
• B052DIQCTPRO0 - QCT Bone Mineral Density Analysis Software: 2018-07-06 The method of Quantitative Computed Tomography (QCT) has been established as a means of non-invasive quantitative bone mineral d
• B052QCTPROM0AS0 - QCT PRO Asynchronous 3D Spine Software: 2018-07-06 Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Mineral Density Analysis Software -
• B052QCTPROM0ASH0 - QCT PRO Asynchronous 3D Spine and CTXA-Hip Softwar: 2018-07-06 Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Mineral Density Analysis Software -
• B052QCTPROM0SS0 - QCT PRO 3D Volumetric Spine Software: 2018-07-06 Convenience Kit consisting of - QCT Bone Mineral Density Analysis Software - Accessories