510(k) K193360— Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard

Substantially Equivalent

Radmedix, LLC

Clearance details

Applicant: Radmedix, LLC
Product code: Code KPR
Advisory panel: Radiology
Date received: 2019-12-04
Decision date: 2020-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dayton, OH, US

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.