Cleared Traditional

K980576 - VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER

K980576 is an FDA 510(k) clearance for VARIAN ENDOMETRIAL APPLICATOR FOR VARIS..., manufactured by Varian Medical Systems, Inc.. The device is a Class 2 Radiology device with product code JAQ cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K980576 · Varian Medical Systems, Inc. · Radiology device
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Nov 1998
Decision
258d
Days
Class 2
Risk

K980576 is an FDA 510(k) clearance for the VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on November 2, 1998 after a review of 258 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 Varian Medical Systems, Inc. devices

FDA 510(k) Submission Details - K980576

510(k) Number K980576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1998
Decision Date November 02, 1998
Days to Decision 258 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 107d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAQ Device Classification - Class 2, Special Controls

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

All 174
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