IDS4 IMAGE DISPLAY SYSTEM SERIES— 510(k) K971368

Substantially Equivalent

O Tech, Inc.

FDA 510(k) clearance K971368 for IDS4 IMAGE DISPLAY SYSTEM SERIES, Substantially Equivalent on 1997-06-26. Applicant: O Tech, Inc..

Clearance details

Applicant: O Tech, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1997-04-14
Decision date: 1997-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.