MAXIRAY 125 TUBE UNIT— 510(k) K781524

Substantially Equivalent

General Electric Co.

FDA 510(k) clearance K781524 for MAXIRAY 125 TUBE UNIT, Substantially Equivalent on 1978-10-17. Applicant: General Electric Co..

Clearance details

Applicant: General Electric Co.
Product code: Code ITY
Advisory panel: Radiology
Date received: 1978-09-05
Decision date: 1978-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.