UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0— 510(k) K062743

Substantially Equivalent

Electronic Business Machine Co., Ltd. (Ebm)

FDA 510(k) clearance K062743 for UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0, Substantially Equivalent on 2006-10-31. Applicant: Electronic Business Machine Co., Ltd. (Ebm).

Clearance details

Applicant: Electronic Business Machine Co., Ltd. (Ebm)
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2006-09-14
Decision date: 2006-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Honolulu, HI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.