Cleared Traditional

CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005

K023110 · Digirad Corp. · Radiology
Nov 2002
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K023110 is an FDA 510(k) clearance for the CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005, 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 November 22, 2002, 64 days after receiving the submission on September 19, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K023110 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2002
Decision Date November 22, 2002
Days to Decision 64 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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