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FDA 510(k)

TruSPECT Processing Station

K-Number: K253532 · 2025-12-30

ApplicantSpectrum Dynamics Medical, Ltd.
Decision Date2025-12-30
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TruSPECT Processing Station is a medical device manufactured by Spectrum Dynamics Medical, Ltd.. It received FDA 510(k) clearance on 2025-12-30 under approval number K253532. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TruSPECT Processing Station?

TruSPECT Processing Station is a medical device that received FDA 510(k) clearance on 2025-12-30. It is manufactured by Spectrum Dynamics Medical, Ltd.. The 510(k) number is K253532.

When was TruSPECT Processing Station approved by the FDA?

TruSPECT Processing Station received FDA 510(k) clearance on 2025-12-30, under approval number K253532.

What company makes TruSPECT Processing Station?

TruSPECT Processing Station is manufactured by Spectrum Dynamics Medical, Ltd..

What is the FDA product code for TruSPECT Processing Station?

The FDA product code for TruSPECT Processing Station is QIH.

Other Devices by Spectrum Dynamics Medical, Ltd.

K161740D-SPECT Scanner, D-SPECT L Scanner K182484VERITON CT whole body SPECT/CT system K180514VERITON NM K190457VERITON CT whole body SPECT/CT system K212230TruSPECT Radiological Image Processing Station K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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