ANALYTICAL REVIEW STATION— 510(k) K955519

Substantially Equivalent

Camtronics, Ltd.

FDA 510(k) clearance K955519 for ANALYTICAL REVIEW STATION, Substantially Equivalent on 1996-05-09. Applicant: Camtronics, Ltd..

Clearance details

Applicant: Camtronics, Ltd.
Product code: Code IZI
Advisory panel: Radiology
Date received: 1995-12-04
Decision date: 1996-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hartland, WI, US

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Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

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.