Cleared Traditional

K913908 - OMNITRON GYN APPLICATOR SYSTEM (FDA 510(k) Clearance)

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

K913908 · Omnitron Intl., Inc. · Radiology device
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Mar 1992
Decision
189d
Days
Class 2
Risk

K913908 is an FDA 510(k) clearance for the OMNITRON GYN APPLICATOR SYSTEM. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Omnitron Intl., Inc. (Houston, US). The FDA issued a Cleared decision on March 6, 1992 after a review of 189 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - 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. Standard predicate reliance. 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 Omnitron Intl., Inc. devices

Submission Details

510(k) Number K913908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1991
Decision Date March 06, 1992
Days to Decision 189 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
82d slower than avg
Panel avg: 107d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
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 - JAQ System, Applicator, Radionuclide, Remote-controlled

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