510(k) Report

FDA applicant

Montifore Medical Center

Bronx, NY1 decision1991–19910 recalls

FDA records 1 decision for Montifore Medical Center (Bronx, NY) in 1991: 1 510(k) clearance. All are in product code JAO (Scanner, Fluorescent). 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 Montifore Medical Center’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Montifore Medical Center since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Montifore Medical Center 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?

  • JAOScanner, Fluorescent1decision

What has FDA decided for it lately?

  • K911749L-Linex-Ray FluorescenceMontifore Medical Center · 1991

The one decision as Montifore Medical Center →