Cleared Special

TruSPECT Radiological Image Processing Station

K212230 · Spectrum Dynamics Medical, Ltd. · Radiology
Aug 2021
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K212230 is an FDA 510(k) clearance for the TruSPECT Radiological Image Processing Station, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Spectrum Dynamics Medical, Ltd. (Caesarea, IL). The FDA issued a Cleared decision on August 16, 2021, 31 days after receiving the submission on July 16, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K212230 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2021
Decision Date August 16, 2021
Days to Decision 31 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050

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