510(k) Report

FDA applicant

Linatech, LLC

Sunnyvale, CA5 decisions2009–20260 recalls

FDA records 5 decisions for Linatech, LLC (Sunnyvale, CA) from 2009 to 2026: 5 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and MUJ (System, Planning, Radiation Therapy Treatment). Its devices cite 4 predicates, 0 of them its own earlier devices. 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 Linatech, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2009: 32024: 12026 (partial year): 1
2009high 3 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Linatech, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Linatech, LLC’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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