510(k) Report

FDA applicant

Fiber Imaging, Inc.

St. Louis, MO1 decision1989–19890 recalls

FDA records 1 decision for Fiber Imaging, Inc. (St. Louis, MO) in 1989: 1 510(k) clearance. All are in product code IYE (Accelerator, Linear, Medical). 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 Fiber Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fiber Imaging, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Fiber Imaging, 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 “Fiber”

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