510(k) Report

FDA applicant

S&S Par Scientific

Great Neck, NY2 decisions1990–20020 recalls

FDA records 2 decisions for S&S Par Scientific (Great Neck, NY) from 1990 to 2002: 2 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and IXI (Block, Beam-Shaping, Radiation Therapy). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is 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 S&S Par Scientific’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for S&S Par Scientific since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — S&S Par Scientific 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?

  • IYEAccelerator, Linear, Medical1decision
  • IXIBlock, Beam-Shaping, Radiation Therapy1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K895697Vac Fix (R) SystemS&S Par Scientific · 19901cites it
  • K021987Parcomplast Compensating Filter for Radiation TherapyS&S Par Scientific · 20021cites it

What has FDA decided for it lately?

  • K021987Parcomplast Compensating Filter for Radiation TherapyS&S Par Scientific · 2002
  • K895697Vac Fix (R) SystemS&S Par Scientific · 1990

All 2 as S&S Par Scientific →