Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright— 510(k) K260087

Substantially Equivalent

GE Medical Systems SCS

FDA 510(k) clearance K260087 for Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright, Substantially Equivalent on 2026-03-24. Applicant: GE Medical Systems SCS.

Clearance details

Applicant: GE Medical Systems SCS
Product code: Code MUE
Advisory panel: Radiology
Date received: 2026-01-12
Decision date: 2026-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buc, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code MUE

product code MUE

Death: 5
Other: 1
Total: 6

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.