Home › Device types › KPS
System, Tomography, Computed, Emission
FDA product code KPS · Class 2 · Radiology
364
Registered devices
1,051
Adverse events
443
Recalls
472
510(k) clearances
Devices with this code
InfinityLock™ — QfixBiograph Vision.X — SIEMENS MEDICAL SOLUTIONS USA, INC.UltraSPECT — Ultraspect Usa, LLCBiograph 16 TruePoint TrueV - 4R — SIEMENS MEDICAL SOLUTIONS USA, INC.Encompass™ — QfixSymbia_T16 — SIEMENS MEDICAL SOLUTIONS USA, INC.VERITON CT — SPECTRUM DYNAMICS MEDICAL, INCMyoSPECT — G E MEDICAL SYSTEMS ISRAEL LTD.UltraSPECT — Ultraspect Usa, LLCPinhole with 4 mm aperture — SIEMENS MEDICAL SOLUTIONS USA, INC.VERITON NM — SPECTRUM DYNAMICS MEDICAL, INCUltraSPECT — Ultraspect Usa, LLCBiograph mCT Flow 64-3R — SIEMENS MEDICAL SOLUTIONS USA, INC.UltraSPECT — Ultraspect Usa, LLCAirShuttle Transfer Handle — QfixBiograph Horizon-3R — SIEMENS MEDICAL SOLUTIONS USA, INC.Affinity — Hermes Medical Solutions ABInfinityLock™ — QfixEncompass™ SRS Fibreplast™ System — QfixBiograph mCT Flow 64-4R — SIEMENS MEDICAL SOLUTIONS USA, INC.VERITON NM — SPECTRUM DYNAMICS MEDICAL, INCEmory Cardiac Toolbox — SYNTERMED INCORPORATEDImagenSPECT — CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.Discovery PET CT — GE Medical Systems, L.L.C.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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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