R-800-SF— 510(k) K904182

Substantially Equivalent

Advantech

FDA 510(k) clearance K904182 for R-800-SF, Substantially Equivalent on 1990-11-13. Applicant: Advantech.

Clearance details

Applicant: Advantech
Product code: Code ITY
Advisory panel: Radiology
Date received: 1990-09-11
Decision date: 1990-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wakefield, MA, US

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Adverse events under product code ITY

product code ITY

Other: 1
Total: 1

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.