280SL IMAGING SYSTEM SMALL PARTS PROBES— 510(k) K864135

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K864135 for 280SL IMAGING SYSTEM SMALL PARTS PROBES, Substantially Equivalent on 1987-01-27. Applicant: Ge Medical Systems Information Technologies.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code ITX
Advisory panel: Radiology
Date received: 1986-10-21
Decision date: 1987-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.