Cleared Special

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

K052430 · Digirad Corp. · Radiology
Oct 2005
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K052430 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 October 4, 2005, 28 days after receiving the submission on September 6, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K052430 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2005
Decision Date October 04, 2005
Days to Decision 28 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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