X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110— 510(k) K910308

Substantially Equivalent

Inmark Corp.

FDA 510(k) clearance K910308 for X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110, Substantially Equivalent on 1991-03-27. Applicant: Inmark Corp..

Clearance details

Applicant: Inmark Corp.
Product code: Code ITY
Advisory panel: Radiology
Date received: 1991-01-24
Decision date: 1991-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, 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.