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TruSPECT Radiological Image Processing Station

K212230 Class II Special
Decision Date
2021-08-16
Sponsor / Applicant
Spectrum Dynamics Medical, Ltd.

Technical Specification

510(k) Submission ID K212230
Product Code LLZ
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.2050
Decision Date 2021-08-16
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

TruSPECT Radiological Image Processing Station received FDA 510(k) clearance under submission number K212230, sponsored by Spectrum Dynamics Medical, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2021-08-16.

Classification & Regulation

This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.