21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A)— 510(k) K081242

Name: FDA 510(k) clearance K081242
Creator: U.S. Food and Drug Administration
Published: 2008-06-11

Substantially Equivalent

Tokotu Electric Co., Ltd.

FDA 510(k) clearance K081242 for 21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A), Substantially Equivalent on 2008-06-11. Applicant: Tokotu Electric Co., Ltd.. Device class: 2.

Clearance details

Applicant: Tokotu Electric Co., Ltd.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2008-05-01
Decision date: 2008-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nagano, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

More clearances from Tokotu Electric Co., Ltd.

view all

K061061 — 20.1-INCH (51CM) COLOR LCD MONITOR CDL2009A (CCL204)2006-06-07

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.