Presero 3D Scanning System— 510(k) K190074

Substantially Equivalent

Certis Health

FDA 510(k) clearance K190074 for Presero 3D Scanning System, Substantially Equivalent on 2019-02-14. Applicant: Certis Health.

Clearance details

Applicant: Certis Health
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2019-01-16
Decision date: 2019-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pompano Beach, FL, US

Download summary PDF View on FDA.gov ↗

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.