Cleared Traditional

K023373 - ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101 (FDA 510(k) Clearance)

Class I Radiology device.

K023373 · Gvi Technology Partners · Radiology device
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Optimized for regulatory review, auditing and printing
Jan 2003
Decision
87d
Days
Class 1
Risk

K023373 is an FDA 510(k) clearance for the ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Gvi Technology Partners (Twinsburg, US). The FDA issued a Cleared decision on January 3, 2003 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - 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.

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Submission Details

510(k) Number K023373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2002
Decision Date January 03, 2003
Days to Decision 87 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
20d faster than avg
Panel avg: 107d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.