CMDR 2C (Multiple Models)— 510(k) K201575

Substantially Equivalent

Minxray, Inc.

FDA 510(k) clearance K201575 for CMDR 2C (Multiple Models), Substantially Equivalent on 2020-07-08. Applicant: Minxray, Inc..

Clearance details

Applicant: Minxray, Inc.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2020-06-11
Decision date: 2020-07-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Northbrook, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

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.