Cleared Traditional

K152018 - Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets

K152018 is an FDA 510(k) clearance for Varian Cleaning Caps, 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 52-day FDA review.

K152018 · Varian Medical Systems, Inc. · Radiology device
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Sep 2015
Decision
52d
Days
Class 2
Risk

K152018 is an FDA 510(k) clearance for the Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Mark.... 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 September 11, 2015 after a review of 52 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Varian Medical Systems, Inc. devices

FDA 510(k) Submission Details - K152018

510(k) Number K152018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2015
Decision Date September 11, 2015
Days to Decision 52 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 107d · This submission: 52d
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 171
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