510(k) Report

FDA applicant

Camtronics Medical Systems

Hartland, WI1 decision2005–200517 recalls

FDA records 1 decision for Camtronics Medical Systems (Hartland, WI) in 2005: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 1 predicate, 0 of them its own earlier devices. 17 recalls are 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 Camtronics Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Camtronics Medical Systems since 2007.

Recalls per year

4in 2025

2015: 42016: 82020: 12025: 4
2007high 8 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Camtronics 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 “Camtronics”

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