Cleared Special

CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM

K051549 · Digirad Corp. · Radiology
Jul 2005
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K051549 is an FDA 510(k) clearance for the CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by Digirad Corp. (Poway, US). The FDA issued a Cleared decision on July 13, 2005, 30 days after receiving the submission on June 13, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K051549 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2005
Decision Date July 13, 2005
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPS — System, Tomography, Computed, Emission
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1200

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