21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035)— 510(k) K133686

Substantially Equivalent

Jvckenwood Corporation

FDA 510(k) clearance K133686 for 21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035), Substantially Equivalent on 2014-01-06. Applicant: Jvckenwood Corporation.

Clearance details

Applicant: Jvckenwood Corporation
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2013-12-02
Decision date: 2014-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokohama-Shi, Kanagawa, JP

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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.