RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31— 510(k) K123186

Substantially Equivalent

Calgary Scientific, Inc.

FDA 510(k) clearance K123186 for RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31, Substantially Equivalent on 2013-03-14. Applicant: Calgary Scientific, Inc..

Clearance details

Applicant: Calgary Scientific, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2012-10-11
Decision date: 2013-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calgary, Alberta, CA

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.