Cleared Special

CARDIUS-1 AND CARDIS-2

K030085 · Digirad Corp. · Radiology
Feb 2003
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K030085 is an FDA 510(k) clearance for the CARDIUS-1 AND CARDIS-2, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by Digirad Corp. (San Diego, US). The FDA issued a Cleared decision on February 5, 2003, 27 days after receiving the submission on January 9, 2003. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K030085 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 2003
Decision Date February 05, 2003
Days to Decision 27 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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