510(k) Report

FDA applicant

Park Medical Systems, Inc.

Lachine Quebec, CA2 decisions1997–19970 recalls

FDA records 2 decisions for Park Medical Systems, Inc. (Lachine Quebec, CA) in 1997: 2 510(k) clearances. All are in product code KPS (System, Tomography, Computed, Emission). 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 Park Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Park Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Park Medical Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Park”

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