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FDA 510(k)

TruSPECT Radiological Image Processing Station

K-Number: K212230 · 2021-08-16

ApplicantSpectrum Dynamics Medical, Ltd.
Decision Date2021-08-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TruSPECT Radiological Image Processing Station is a medical device manufactured by Spectrum Dynamics Medical, Ltd.. It received FDA 510(k) clearance on 2021-08-16 under approval number K212230. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TruSPECT Radiological Image Processing Station?

TruSPECT Radiological Image Processing Station is a medical device that received FDA 510(k) clearance on 2021-08-16. It is manufactured by Spectrum Dynamics Medical, Ltd.. The 510(k) number is K212230.

When was TruSPECT Radiological Image Processing Station approved by the FDA?

TruSPECT Radiological Image Processing Station received FDA 510(k) clearance on 2021-08-16, under approval number K212230.

What company makes TruSPECT Radiological Image Processing Station?

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

What is the FDA product code for TruSPECT Radiological Image Processing Station?

The FDA product code for TruSPECT Radiological Image Processing Station is LLZ.

Related Clinical Trials

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Related PubMed Literature

PMID: 39941212 Artificial Intelligence-Empowered Radiology-Current Status and Critical Review. Diagnostics (Basel, Switzerland) (2025)

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 K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) K253532TruSPECT Processing Station

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Related Devices (Code: LLZ)

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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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