510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881665Substantially Equivalent

Omnitron Remote Controlled Radionuclide Applicator

Omnitron Intl., Inc., New Orleans LA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881665 is the FDA 510(k) clearance record for OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR, a class II device, cleared for Omnitron Intl., Inc. on under FDA product code JAQ (System, Applicator, Radionuclide, Remote-Controlled). FDA records list 7 510(k) clearances for Omnitron Intl., Inc., from to . As of , FDA records show no recalls naming K881665.

Clearance record

Decision date
Received
(115 days to decision)
Product code
JAQ System, Applicator, Radionuclide, Remote-Controlled
Regulation
21 CFR 892.5700
Device class
Class II
Review panel
Radiology
Applicant
Omnitron Intl., Inc. 3839 Ulloa St., New Orleans LA
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