510(k) Report

FDA applicant

Rts Technology, Inc.

North Andover, MA3 decisions1990–19922 recalls

FDA records 3 decisions for Rts Technology, Inc. (North Andover, MA) from 1990 to 1992: 3 510(k) clearances. All are in product code JAQ (System, Applicator, Radionuclide…). 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Rts Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rts Technology, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rts Technology, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JAQSystem, Applicator, Radionuclide, Remote-Controlled3decisions

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K912555Gammamed 12IT High Dose Rate Remote AfterloaderRts Technology, Inc. · 19911cites it

What has FDA decided for it lately?

  • K914578RTS Technology Models 721,722,723,724Rts Technology, Inc. · 1992
  • K912555Gammamed 12IT High Dose Rate Remote AfterloaderRts Technology, Inc. · 19912 recalls
  • K901589RTS Technology Iridium 192 SourcesRts Technology, Inc. · 1990

All 3 as Rts Technology, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K891131GammaMed 12i radionuclide applicator systems, distributed by Varian Medical Systems…Sep 11, 2006
  • K912555GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row…May 1, 2006