EXAPACS— 510(k) K093444

Substantially Equivalent

Medincom Technology Corp

FDA 510(k) clearance K093444 for EXAPACS, Substantially Equivalent on 2010-02-04. Applicant: Medincom Technology Corp.

Clearance details

Applicant: Medincom Technology Corp
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2009-11-05
Decision date: 2010-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei Hsien, TW

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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.