QCT Pro Asynchronous Calibration Module, CliniQCT
The QCT Pro Asynchronous Calibration Module, CliniQCT, provides an alternative method for calibrating CT datasets analyzed with QCT Pro Spine and Hip application modules. The filing says…
The QCT Pro Asynchronous Calibration Module, CliniQCT, provides an alternative method for calibrating CT datasets analyzed with QCT Pro Spine and Hip application modules.
The filing says this method provides calibration data without requiring a simultaneous patient scan with a CT calibration standard. It also supports retrospective bone-density assessment from CT scans acquired for other purposes.
Listed Item
The QCT Pro Asynchronous Calibration Module is intended to provide an alternative method for calibrating QCT data sets that are intended for analysis with QCT Pro Spine and Hip application modules. Installation of the QCT Pro Asynchronous Calibration Module does not alter the clinical indications for use of the QCT Pro Spine and Hip application modules. It does, however, provide an additional means of obtaining calibration data that does not require the simultaneous scanning of a patient with a CT calibration standard as is required when using the QCT Pro Spine and Hip application modules without the installation of the QCT Pro Asynchronous Calibration Module. Thus the QCT Pro Asynchronous Calibration Module facilitates: (1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans of the anatomical regions where estimating bone density is prescribed, and (3) assessment of bone density without a phantom as an independent measurement procedure.
Calibration Data
The filing describes phantom measurements from the same CT scanner, operated in a substantially similar mode to the patient scan. These measurements may be taken before or after the scan to which they apply.
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
Record
| Listed by | Mindways Software, Inc., United States |
|---|---|
| FDA product code | KGI |
| Device type | Densitometer, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1170 |
| Establishment | Manufacturer |
| 510(k) | K140342 |
| Record published | 2017-03-31 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K140342 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TBS iNsight | Medimaps Group SA | 6 |
| Prodigy | GE Medical Systems Ultrasound & Primary Care Diagnostics LLC | 4 |
| 3D-SHAPER | 3D-SHAPER Medical S.L. | 2 |
| QCT PRO Asynchronous 3D Spine and CTXA-Hip System | Mindways Software, Inc. | 2 |
| Densitometer, Bone | Stratec Medizintechnik Gmbh | 2 |
| Horizon Ci | Hologic, Inc. | 1 |
| XR-600 Basic | Norland at Swissray | 1 |
| Discovery A | Hologic, Inc. | 1 |
| Medimaps TBS iNsight | Medimaps Group SA | 1 |
| Model 4 CT Calibration Phantom | Mindways Software, Inc. | 1 |
| Discovery SL | Hologic, Inc. | 1 |
| IlluminatusDXA Software | Norland at Swissray | 1 |
Showing 12 of 38. All products under Densitometer, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140342 | 2014-08-29 |
| K030330 | 2003-06-20 |
| K002113 | 2001-12-04 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.