Model 4 CT Calibration Phantom

GUDID B052PHCTM40

Calibration phantom intended for use as an accessory to the QCT Pro Bone Mineral Densitometry Software.

MINDWAYS SOFTWARE, INC.

Bone densitometry x-ray phantom, test object Bone densitometry x-ray phantom, test object Bone densitometry x-ray phantom, test object Bone densitometry x-ray phantom, test object Bone densitometry x-ray phantom, test object Bone densitometry x-ray phantom, test object Bone densitometry x-ray phantom, test object Bone densitometry x-ray phantom, test object Bone densitometry x-ray phantom, test object Bone densitometry x-ray phantom, test object Bone densitometry x-ray phantom, test object Bone densitometry x-ray phantom, test object Bone densitometry x-ray phantom, test object Bone densitometry x-ray phantom, test object Bone densitometry x-ray phantom, test object Bone densitometry x-ray phantom, test object Bone densitometry x-ray phantom, test object

• Primary Device ID: B052PHCTM40
• NIH Device Record Key: a19b2f0d-df0b-4831-a2a2-f2fa65aa0741
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Model 4 CT Calibration Phantom
• Version Model Number: 4
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B052PHCTM40 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-12
• Device Publish Date: 2023-05-04

Devices Manufactured by MINDWAYS SOFTWARE, INC.

• B052PHCTM40 - Model 4 CT Calibration Phantom: 2023-05-12Calibration phantom intended for use as an accessory to the QCT Pro Bone Mineral Densitometry Software.
• 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