Discovery A
Catalogue number Discovery A, listed by Hologic, Inc., United States, under Densitometer, Bone. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
29510(k) clearances naming this product code
11recalls on this 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 | Hologic, Inc., United States |
|---|---|
| FDA product code | KGI |
| Device type | Densitometer, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1170 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K023398 |
| Record published | 2017-09-22 |
| Record revised | 2024-01-03 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -30 to 50 °C; Handling environment temperature 15 to 32 °C |
| Distribution end date | 2020-01-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Discovery A | Withdrawn |
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 |
| QCT Pro Asynchronous Calibration Module, CliniQCT | Mindways Software, Inc. | 1 |
| XR-600 Basic | Norland at Swissray | 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 |
|---|---|
| K130277 | 2013-05-31 |
| K113356 | 2012-03-06 |
| K103265 | 2011-03-16 |
| K080711 | 2008-09-02 |
| K072847 | 2008-03-28 |
| K061561 | 2006-07-28 |
| K060111 | 2006-04-24 |
| K042480 | 2004-10-29 |
| K041266 | 2004-08-11 |
| K033224 | 2003-11-05 |
| K023398 | 2002-11-08 |
| K002711 | 2000-09-28 |
| K992775 | 1999-10-01 |
| K992677 | 1999-09-03 |
| K983028 | 1998-11-13 |
| K961787 | 1997-06-13 |
| K963363 | 1996-11-22 |
| K941362 | 1995-08-30 |
| K943505 | 1995-01-20 |
| K926300 | 1993-07-23 |
| K913321 | 1991-11-01 |
| K905753 | 1991-06-10 |
| K905691 | 1991-05-15 |
| K894795 | 1990-08-30 |
| K890999 | 1989-12-21 |
| K883280 | 1988-09-29 |
| K883360 | 1988-09-27 |
| K871446 | 1987-10-20 |
| K871553 | 1987-10-08 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Hologic, Inc. | 510(k) number | 2024-06-13 | Class II | Under Investigation by firm | Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the result from the Horiz | 2,642 units (1037 units US; 1605 units OUS) |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-04-07 | Not classified | Component design/selection | System may not turn off at the end of the x-ray and cause additional x-ray exposure | 1914 units total | 2010-11-29 |
| 2009-04-07 | Not classified | Component design/selection | System may not turn off at the end of the x-ray and cause additional x-ray exposure | 1914 units total | 2010-11-29 |
| 2009-04-07 | Not classified | Component design/selection | System may not turn off at the end of the x-ray and cause additional x-ray exposure | 1914 units total | 2010-11-29 |
| 2009-04-07 | Not classified | Component design/selection | System may not turn off at the end of the x-ray and cause additional x-ray exposure | 1914 units total | 2010-11-29 |
| 2008-09-24 | Not classified | Software design | Software error may lead to a high estimate of major fracture probability. | 15 software discs | 2016-03-07 |
| 2008-06-27 | Not classified | Software design | Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. | 325 units | 2010-10-25 |
| 2008-06-27 | Not classified | Software design | Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. | 534 units | 2010-10-25 |
| 2008-06-27 | Not classified | Software design | Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. | 212 units | 2010-10-25 |
| 2008-06-27 | Not classified | Software design | Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. | 15 units | 2010-10-25 |
| 2008-06-27 | Not classified | Software design | Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. | 82 units | 2010-10-25 |
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.