CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO— 510(k) K905801

Substantially Equivalent

Cemax, Inc.

FDA 510(k) clearance K905801 for CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO, Substantially Equivalent on 1991-03-22. Applicant: Cemax, Inc..

Clearance details

Applicant: Cemax, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1990-12-28
Decision date: 1991-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, 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.