CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris— 510(k) K171353

Substantially Equivalent

Minxray, Inc.

FDA 510(k) clearance K171353 for CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris, Substantially Equivalent on 2017-06-07. Applicant: Minxray, Inc..

Clearance details

Applicant: Minxray, Inc.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2017-05-09
Decision date: 2017-06-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Northbrook, IL, US

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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.