MREplus+ Software— 510(k) K183193

Substantially Equivalent

Resoundant, Inc.

FDA 510(k) clearance K183193 for MREplus+ Software, Substantially Equivalent on 2019-08-01. Applicant: Resoundant, Inc..

Clearance details

Applicant: Resoundant, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2018-11-19
Decision date: 2019-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, MN, US

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.