ULTRA COMPACT VIDEO IMAGER— 510(k) K930765

Substantially Equivalent

International Imaging Electronics

FDA 510(k) clearance K930765 for ULTRA COMPACT VIDEO IMAGER, Substantially Equivalent on 1993-09-13. Applicant: International Imaging Electronics.

Clearance details

Applicant: International Imaging Electronics
Product code: Code JAK
Advisory panel: Radiology
Date received: 1993-02-12
Decision date: 1993-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bolingbrook, IL, US

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Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.