510(k) Report

FDA applicant

Xerox Medical Systems

Mchenry, IL5 decisions1979–19850 recalls

FDA records 5 decisions for Xerox Medical Systems (Mchenry, IL) from 1979 to 1985: 5 510(k) clearances. Most are in product codes IZH (System, X-Ray, Mammographic) and KPX (Changer, Radiographic Film/Cassette). 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 Xerox Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Xerox Medical Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Xerox”

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