DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI— 510(k) K080351

Substantially Equivalent

Dexela, Ltd.

FDA 510(k) clearance K080351 for DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI, Substantially Equivalent on 2008-04-22. Applicant: Dexela, Ltd..

Clearance details

Applicant: Dexela, Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2008-02-11
Decision date: 2008-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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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.