Cleared Traditional

STASYS MOTION CORRECTION SOFTWARE

K082904 · Digirad Corp. · Radiology
Dec 2008
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K082904 is an FDA 510(k) clearance for the STASYS MOTION CORRECTION SOFTWARE, 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 December 17, 2008, 78 days after receiving the submission on September 30, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K082904 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2008
Decision Date December 17, 2008
Days to Decision 78 days
Submission Type Traditional
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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