QCT PRO Asynchronous 3d Spine and CTXA-Hip System
Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended…
Convenience Kit consisting of – QCT Pro Asynchronous Calibration Module, CliniQCT – QCT Bone Mineral Density Analysis Software – CTXA Hip Bone Mineral Densitometer – CTXA Hip Extended Reference Database – Model 3 QA & Calibration Phantom Set
1manufacturer
2catalogue numbers in this listing
3510(k) clearances naming this product code
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) | K002113 |
| 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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
| Storage | Handling environment temperature -40 to 60 °C |
| Packaging | Carton/box of 100, carton/box of 75, carton/box of 50, carton/box of 25, carton/box of 10, carton/box of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K894854K002113K030330K140342 | In distribution | |
| K894854K002113K030330K140342 | 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 |
| Densitometer, Bone | Stratec Medizintechnik Gmbh | 2 |
| Horizon Ci | Hologic, Inc. | 1 |
| QCT Pro Asynchronous Calibration Module, CliniQCT | Mindways Software, 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.