| Primary Device ID | B052QCTPROM3ASH0 |
| NIH Device Record Key | 9405314a-63bc-4a8d-a4b3-6b013aeeca52 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QCT PRO Asynchronous 3D Spine and CTXA-Hip System |
| Version Model Number | K894854K002113K030330K140342 |
| Catalog Number | QCTPROM3ASH |
| 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 |
| Phone | +1 512 912-0871 |
| info@qct.com | |
| Phone | +1 512 912-0871 |
| info@qct.com |
| Handling Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B052QCTPROM3ASH0 [Primary] |
| KGI | Densitometer, Bone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-03-31 |
| 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 |