510(k) Report

FDA applicant

Swiss Ray Medical Systems

Mobile, AL3 decisions1992–19920 recalls

FDA records 3 decisions for Swiss Ray Medical Systems (Mobile, AL) in 1992: 3 510(k) clearances. Most are in product codes KPR (System, X-Ray, Stationary) and IZO (Generator, High-Voltage, X-Ray, Diagnostic). 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 Swiss Ray Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Swiss Ray Medical Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Swiss Ray Medical Systems 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?

  • KPRSystem, X-Ray, Stationary2decisions
  • IZOGenerator, High-Voltage, X-Ray, Diagnostic1decision

What has FDA decided for it lately?

  • K922813Gen-X 800-400 -- ModificationSwiss Ray Medical Systems · 1992
  • K921539GEN-X 800/6/50Swiss Ray Medical Systems · 1992
  • K915227GEN-X 800/500Swiss Ray Medical Systems · 1992

All 3 as Swiss Ray Medical Systems →

Other applicant names beginning “Swiss”

FDA records each applicant name separately; these may or may not be the same firm.

Swiss American Metal Craft Corp. 4Swiss American Products, Inc. 4Swiss Orthopedic Solutions, Inc. 1Swiss Precision Mfg. Corp. 1Swiss Dental Center 1Swiss Medical Care S.A. 1