510(k) Report

FDA applicant

Telediagnostic Systems, Inc.

San Francisco, CA14 decisions1978–20070 recalls

FDA records 14 decisions for Telediagnostic Systems, Inc. (San Francisco, CA) from 1978 to 2007: 14 510(k) clearances. Most are in product codes GYE (Encephalogram Telemetry System) and GWK (Conditioner, Signal, Physiological). 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, neurology panel, where it files most

How often FDA has decided Telediagnostic Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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