510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983436Substantially Equivalent

Gammamed Plus High Dose Rate Remote Afterloading System

Gammamed USA, Ann Arbor MI / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K983436 is the FDA 510(k) clearance record for GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM, a class II device, cleared for Gammamed USA on under FDA product code JAQ (System, Applicator, Radionuclide, Remote-Controlled). FDA records list one 510(k) clearance for Gammamed USA. As of , FDA records show 17 recalls naming K983436.

Clearance record

Decision date
Received
(30 days to decision)
Product code
JAQ System, Applicator, Radionuclide, Remote-Controlled
Regulation
21 CFR 892.5700
Device class
Class II
Review panel
Radiology
Applicant
Gammamed USA 2464 E. Stadium Way, Ann Arbor MI
510(k) summary
Summary
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