5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2)— 510(k) K061447

Substantially Equivalent

Totoku Electric Co., Ltd.

FDA 510(k) clearance K061447 for 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2), Substantially Equivalent on 2006-07-21. Applicant: Totoku Electric Co., Ltd..

Clearance details

Applicant: Totoku Electric Co., Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2006-05-25
Decision date: 2006-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nagano, JP

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.