510(k) K922647— COLOR DISKSTORE

Substantially Equivalent

Camtronics, Ltd.

Clearance details

Applicant: Camtronics, Ltd.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1992-06-03
Decision date: 1992-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hartland, WI, US

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.