PID-1 PRECISION INTELLIGENT DOSIMETER— 510(k) K954564

Substantially Equivalent

Gammex, Inc.

FDA 510(k) clearance K954564 for PID-1 PRECISION INTELLIGENT DOSIMETER, Substantially Equivalent on 1996-04-22. Applicant: Gammex, Inc..

Clearance details

Applicant: Gammex, Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 1995-10-02
Decision date: 1996-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middleton, WI, US

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Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.