Cleared Traditional

SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM (K092713) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 95
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