Cleared Traditional

SPECTURN, MODEL TTK-128 (K923180) - FDA 510(k) Clearance

Class I Radiology device.

K923180 · Harpell Assoc., Inc. · Radiology device
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Jul 1993
Decision
391d
Days
Class 1
Risk

K923180 is an FDA 510(k) clearance for the SPECTURN, MODEL TTK-128. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Harpell Assoc., Inc. (Oakville, Ontario, CA). The FDA issued a Cleared decision on July 26, 1993 after a review of 391 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Harpell Assoc., Inc. devices

Submission Details

510(k) Number K923180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1992
Decision Date July 26, 1993
Days to Decision 391 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
284d slower than avg
Panel avg: 107d · This submission: 391d
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.

Regulatory Peers - IYX Camera, Scintillation (gamma)

All 29
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