510(k) Report

FDA applicant

S & S X-Ray Products, Inc.

Brooklyn, NY4 decisions1985–20030 recalls

FDA records 4 decisions for S & S X-Ray Products, Inc. (Brooklyn, NY) from 1985 to 2003: 4 510(k) clearances. Most are in product codes IZH (System, X-Ray, Mammographic) and IXI (Block, Beam-Shaping, Radiation Therapy). Its devices cite 1 predicate, 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 X-Ray Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for S & S X-Ray Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — S & S X-Ray Products, 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?

  • IZHSystem, X-Ray, Mammographic2decisions
  • IXIBlock, Beam-Shaping, Radiation Therapy1decision
  • IYEAccelerator, Linear, Medical1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K031574Squeeze-Ease Mammography CushionS & S X-Ray Products, Inc. · 2003
  • K944040Planet Thermoplastic Immobilization SystemS & S X-Ray Products, Inc. · 1995
  • K883317DCD-1 (Digital Contour Detect-Radiat Therapy) SystS & S X-Ray Products, Inc. · 1989
  • K850614Sand S MB12 Mammography Moving Grid BuckyS & S X-Ray Products, Inc. · 1985

All 4 as S & S X-Ray Products, Inc. →