510(k) Report

FDA applicant

The Complete Systems Corp. Genesys

Maitland, FL1 decision1991–19910 recalls

FDA records 1 decision for The Complete Systems Corp. Genesys (Maitland, FL) in 1991: 1 510(k) clearance. All are in product code JAI (Couch, Radiation Therapy, Powered). 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 The Complete Systems Corp. Genesys’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Complete Systems Corp. Genesys since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — The Complete Systems Corp. Genesys by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “The”

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