CZT Upgrade
Catalogue number H3906DE, listed by G E Medical Systems Israel Ltd., under System, Tomography, Computed, Emission. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Beijing (1), Shanghai (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Neusoft Positron Medical Systems Co., Ltd. | Shen Yang | Liaoning | Manufacturer | 1 |
Record
| Listed by | G E Medical Systems Israel Ltd. |
|---|---|
| FDA product code | KPS |
| Device type | System, Tomography, Computed, Emission |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1200 |
| 510(k) | K153402 |
| Record published | 2018-05-15 |
| Record revised | 2026-01-30 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H3906DE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NeuroQ | Syntermed, Inc. | 11 |
| Emory Cardiac Toolbox | Syntermed, Inc. | 10 |
| Discovery | GE Medical Systems, L.L.C. | 7 |
| uMI | Shanghai United Imaging Healthcare Co., Ltd. | 7 |
| Brightonix | Brightonix Imaging Inc. | 6 |
| UltraSPECT | Ultraspect USA, LLC | 5 |
| Discovery | G E Medical Systems Israel Ltd. | 5 |
| Veriton CT | Spectrum Dynamics Medical Ltd. | 5 |
| Cardius 2 | Digirad Corp. | 4 |
| Encompass™ SRS Fibreplast™ System | Qfix | 4 |
| Veriton NM | Spectrum Dynamics Medical Ltd. | 3 |
| Cedars-Sinai Cardiac Suite | Cedars Sinai Medical Center | 3 |
Showing 12 of 172. All products under System, Tomography, Computed, Emission
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| GE Medical Systems Israel, Functional Imaging | 510(k) number | 2022-12-19 | Class I | Process control | A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury. | 86 units | |
| GE Medical Systems, LLC | 510(k) number | 2020-12-10 | Class II | Process control | GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector. | 12 units | 2026-08-21 |
| GE Medical Systems, LLC | 510(k) number | 2020-08-14 | Class II | Use error | Rotor bearing screws were found loose on detector. | 15 units | 2021-05-06 |
| GE Medical Systems, LLC | 510(k) number | 2019-03-20 | Class II | Device Design | During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy. | 3 units | 2020-10-05 |
| GE Medical Systems, LLC | 510(k) number | 2019-03-20 | Class II | Device Design | During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy. | 16 units | 2020-10-05 |
| GE Medical Systems, LLC | 510(k) number | 2017-05-19 | Class II | Software design | It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. | 10,884 | 2018-07-29 |
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.