Cleared Traditional

QUANTEC SPINAL MEASUEMENT SYSTEM (K923792) - FDA 510(k) Clearance

K923792 · Quantec Image Processing , Ltd. · Physical Medicine device
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Apr 1994
Decision
631d
Days
-
Risk

K923792 is an FDA 510(k) clearance for the QUANTEC SPINAL MEASUEMENT SYSTEM. Classified as Device, Sensing, Optical Contour (product code LDK).

Submitted by Quantec Image Processing , Ltd. (Madison, US). The FDA issued a Cleared decision on April 20, 1994 after a review of 631 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Quantec Image Processing , Ltd. devices

Submission Details

510(k) Number K923792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1992
Decision Date April 20, 1994
Days to Decision 631 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
516d slower than avg
Panel avg: 115d · This submission: 631d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDK Device, Sensing, Optical Contour
Device Class -