K252178

Substantially Equivalent

MAGENTIQ-COLO (ME-APDS)

Applicant: Magentiq Eye, Ltd.
Product code: QNP
Advisory panel: Gastroenterology, Urology
Date received: 2025-07-11
Decision date: 2025-10-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Haifa, IL

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.