Cleared Traditional

K092713 - SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM

K092713 is an FDA 510(k) clearance for SPECTRE WIRELESS ENCRYPTED FOOTSWITCH A..., manufactured by Transamerican Medical Imaging. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K092713 · Transamerican Medical Imaging · Radiology device
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Jul 2010
Decision
316d
Days
Class 2
Risk

K092713 is an FDA 510(k) clearance for the SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Transamerican Medical Imaging (Lindon, US). The FDA issued a Cleared decision on July 16, 2010 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - 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 Transamerican Medical Imaging devices

FDA 510(k) Submission Details - K092713

510(k) Number K092713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2009
Decision Date July 16, 2010
Days to Decision 316 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
209d slower than avg
Panel avg: 107d · This submission: 316d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IZL Device Classification - Class 2, Special Controls

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

All 154
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