Cleared Traditional

CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005 (K023110) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K023110 is an FDA 510(k) clearance for the CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Digirad Corp. (San Diego, US). The FDA issued a Cleared decision on November 22, 2002 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Digirad Corp. devices

Submission Details

510(k) Number K023110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 148
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K023110.
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GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM
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GE ROAD WARRIOR PET CT IMAGING SYSTEM
K022872 · General Electric Co. · Sep 2002
GE VISION NUCLEAR MEDICINE WORKSTATION
K012568 · General Electric Co. · Sep 2001
ORBITER II CCI/SPECT ORBITER II CCI/SPECT
K010137 · Siemens Medical Solutions USA, Inc. · Feb 2001