QCT PRO Asynchronous 3D Spine and CTXA-Hip System QCTPROM4ASH

GUDID B052QCTPROM4ASH0

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

MINDWAYS SOFTWARE, INC.

CT system application software

• Primary Device ID: B052QCTPROM4ASH0
• NIH Device Record Key: 21b567c2-1541-4b16-ab63-427184539701
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QCT PRO Asynchronous 3D Spine and CTXA-Hip System
• Version Model Number: K894854K002113K030330K140342
• Catalog Number: QCTPROM4ASH
• 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	B052QCTPROM4ASH0 [Primary]
HIBCC	QCTPROM4ASHN0002 [Package]; Package: Carton/Box [2 Units]; In Commercial Distribution
HIBCC	QCTPROM4ASHN0003 [Package]; Package: Carton/Box [3 Units]; In Commercial Distribution
HIBCC	QCTPROM4ASHN0005 [Package]; Package: Carton/Box [5 Units]; In Commercial Distribution
HIBCC	QCTPROM4ASHN0010 [Package]; Package: Carton/Box [10 Units]; In Commercial Distribution
HIBCC	QCTPROM4ASHN0025 [Package]; Package: Carton/Box [25 Units]; In Commercial Distribution
HIBCC	QCTPROM4ASHN0050 [Package]; Package: Carton/Box [50 Units]; In Commercial Distribution
HIBCC	QCTPROM4ASHN0075 [Package]; Package: Carton/Box [75 Units]; In Commercial Distribution
HIBCC	QCTPROM4ASHN0100 [Package]; Package: Carton/Box [100 Units]; In Commercial Distribution
HIBCC	QCTPROM4ASHN0200 [Package]; Package: Carton/Box [200 Units]; In Commercial Distribution
HIBCC	QCTPROM4ASHN0500 [Package]; Package: Carton/Box [500 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002113

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

On-Brand Devices [QCT PRO Asynchronous 3D Spine and CTXA-Hip System]

• B052QCTPROM4ASH0: Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Min
• B052QCTPROM3ASH0: Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Min