510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K000081Substantially Equivalent

Manual and Remote Controlled Applicator System

Isotopes and Metals, Ltd., Geneva, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000081 is the FDA 510(k) clearance record for MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM, a class II device, cleared for Isotopes and Metals , Ltd. on under FDA product code JAQ (System, Applicator, Radionuclide, Remote-Controlled). FDA records list one 510(k) clearance for Isotopes and Metals , Ltd. As of , FDA records show no recalls naming K000081.

Clearance record

Decision date
Received
(343 days to decision)
Product code
JAQ System, Applicator, Radionuclide, Remote-Controlled
Regulation
21 CFR 892.5700
Device class
Class II
Review panel
Radiology
Applicant
Isotopes and Metals , Ltd. 29, Ch De Grange Canal, Geneva, CH
510(k) summary
Statement
Third party review
No

Clearances, product code JAQ

Trailing 12 months
4 clearances under product code JAQ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JAQ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260