Cleared Traditional

K923180 - SPECTURN, MODEL TTK-128

K923180 is an FDA 510(k) clearance for SPECTURN, manufactured by Harpell Assoc., Inc.. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 391-day FDA review.

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

FDA 510(k) Submission Details - K923180

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.

IYX Device Classification - Class 1, General Controls

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 89
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