Home › Device types › KPS
System, Tomography, Computed, Emission
FDA product code KPS · Class 2 · Radiology
369
Registered devices
1,054
Adverse events
449
Recalls
473
510(k) clearances
Devices with this code
uMI — Shanghai United Imaging Healthcare Co., Ltd.BodyMD — Ddd-Diagnostic A/SDiscovery — G E MEDICAL SYSTEMS ISRAEL LTD.InfinityLock™ — QfixMyoSPECT — G E MEDICAL SYSTEMS ISRAEL LTD.DELTAmanager — MEDIMAGE, INC.830 to 870 DR Upgrade — G E MEDICAL SYSTEMS ISRAEL LTD.Encompass™ — QfixBiograph mCT Flow Edge-3R — SIEMENS MEDICAL SOLUTIONS USA, INC.BoS™ AirShuttle™ — QfixLow Energy Ultra HighRes Collimator — SIEMENS MEDICAL SOLUTIONS USA, INC.Symbia_Intevo_16 — SIEMENS MEDICAL SOLUTIONS USA, INC.UltraSPECT — Ultraspect Usa, LLC870ES to 870 DR Upgrade — G E MEDICAL SYSTEMS ISRAEL LTD.UHRES Collimator Asm Symbia — SIEMENS MEDICAL SOLUTIONS USA, INC.850ES to 850 Upgrade — G E MEDICAL SYSTEMS ISRAEL LTD.BRIGHTONIX — Brightonix Imaging Inc.Biograph mCT S(64)-4R — SIEMENS MEDICAL SOLUTIONS USA, INC.Optima — G E MEDICAL SYSTEMS ISRAEL LTD.860ES to 860 Upgrade — G E MEDICAL SYSTEMS ISRAEL LTD.Ingenuity TF — Philips Medical Systems (cleveland), Inc.CAREMIBRAIN — GENERAL EQUIPMENT FOR MEDICAL IMAGING SADiscovery — GE Medical Systems, L.L.C.TOSHIBA SCANNER — CANON INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are m |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are m |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are m |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are m |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are m |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are m |
| 2025-12-24 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking |
| 2025-12-10 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and l |
| 2025-12-10 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and l |
| 2025-09-12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated withou |
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