510(k) K023110

CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005 by Digirad Corp. — Product Code KPS

K023110 is an FDA 510(k) premarket notification submitted by Digirad Corp. for the device "CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005". The FDA issued a decision of Substantially Equivalent on November 22, 2002. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Digirad Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2002
Date Received
September 19, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type