| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | B052PHCTM40 [Primary] |
| KGI | Densitometer, Bone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-12 |
| Device Publish Date | 2023-05-04 |
| 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 |