Cleared Traditional

K000081 - MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM

K000081 is an FDA 510(k) clearance for MANUAL AND REMOTE CONTROLLED APPLICATOR..., manufactured by Isotopes and Metals , Ltd.. The device is a Class 2 Radiology device with product code JAQ cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K000081 · Isotopes and Metals , Ltd. · Radiology device
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Dec 2000
Decision
343d
Days
Class 2
Risk

K000081 is an FDA 510(k) clearance for the MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Isotopes and Metals , Ltd. (Geneva, CH). The FDA issued a Cleared decision on December 19, 2000 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Isotopes and Metals , Ltd. devices

FDA 510(k) Submission Details - K000081

510(k) Number K000081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2000
Decision Date December 19, 2000
Days to Decision 343 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
236d slower than avg
Panel avg: 107d · This submission: 343d
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 158
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