Ox-Imager CS— 510(k) K153426

Substantially Equivalent

Modulated Imaging, Inc.

FDA 510(k) clearance K153426 for Ox-Imager CS, Substantially Equivalent on 2016-12-21. Applicant: Modulated Imaging, Inc..

Clearance details

Applicant: Modulated Imaging, Inc.
Product code: Code MUD
Advisory panel: Cardiovascular
Date received: 2015-11-25
Decision date: 2016-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MUD

product code MUD

Malfunction: 467
Total: 467

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.