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Catalogue number H3100CF, 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) | K093514 |
| Record published | 2017-06-28 |
| Record revised | 2026-01-30 (version 4) |
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 |
|---|---|---|
| H3100CF | 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
21 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 | 2024-12-18 | Class II | Package design/selection | GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transporte | 859 units | |
| GE Medical Systems Israel, Functional Imaging | 510(k) number | 2024-12-18 | Class II | Package design/selection | GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transporte | 283 units | |
| GE Medical Systems Israel, Functional Imaging | 510(k) number | 2024-12-18 | Class II | Package design/selection | GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transporte | 17 units | |
| GE Medical Systems Israel, Functional Imaging | 510(k) number | 2024-12-18 | Class II | Package design/selection | GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transporte | 8 units | |
| 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. | 557 units | |
| GE Medical Systems, LLC | 510(k) number | 2021-02-07 | Class II | Device Design | GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workf | 242 in total (17 units US) | |
| 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. | 52 untits | 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. | 20 units | 2021-05-06 |
| GE Medical Systems, LLC | 510(k) number | 2020-08-14 | Class II | Use error | Rotor bearing screws were found loose on detector. | 9 units | 2021-05-06 |
| GE Medical Systems, LLC | 510(k) number | 2020-08-14 | Class II | Use error | Rotor bearing screws were found loose on detector. | 31 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. | 11 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. | 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. | 27 units | 2020-10-05 |
| GE Medical Systems, LLC | 510(k) number | 2018-05-24 | Class II | Component change control | When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could result in these not shutting off all power to the entir | 4 units | |
| GE Medical Systems, LLC | 510(k) number | 2018-05-24 | Class II | Component change control | When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could result in these not shutting off all power to the entir | 2 units | |
| GE Medical Systems, LLC | 510(k) number | 2018-05-24 | Class II | Component change control | When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could result in these not shutting off all power to the entir | 1 unit | |
| 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 |
| GE Medical Systems, LLC | 510(k) number | 2013-10-25 | Class II | Employee error | GE Healthcare has recently become aware of a potential safety issue related to a SPECT scan procedure used for pulmonary imaging. Contact between the Detector (GE Healthcare Discovery NM/CT 670, and/or Optima NM/CT 640, and/or Discovery | 464 (143 US, 321 OUS) | 2014-04-01 |
| GE Medical Systems, LLC | 510(k) number | 2013-06-13 | Class I | Device Design | GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals | 213 | 2014-06-19 |
| GE Medical Systems, LLC | 510(k) number | 2012-10-12 | Class II | Software design | GE Healthcare has recently become aware of a potential safety issue associated with the table pallet of your Discovery NM/CT 670 and/or Discovery NM630 system which may impact operation safety. At scan setup, during gantry rotation towards | 210 | 2013-11-14 |
| GE Medical Systems, LLC | 510(k) number | 2012-01-11 | Not classified | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue associated with the collimator cart and lead cover of your Discovery NM/CT 670 and/or Discovery NM 630 system that may impact operator safety. 1. The cart locking pin rel | 79 | 2012-12-06 |
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.