XR-910— 510(k) K981466

Substantially Equivalent

Imaging Sciences Intl., Inc.

FDA 510(k) clearance K981466 for XR-910, Substantially Equivalent on 1998-07-14. Applicant: Imaging Sciences Intl., Inc..

Clearance details

Applicant: Imaging Sciences Intl., Inc.
Product code: Code IZL
Advisory panel: Radiology
Date received: 1998-04-23
Decision date: 1998-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roebling, NJ, US

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Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

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.