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

Name: FDA 510(k) clearance K193360
Creator: U.S. Food and Drug Administration
Published: 2020-01-02

Substantially Equivalent

Radmedix, LLC

FDA 510(k) clearance K193360 for Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard, Substantially Equivalent on 2020-01-02. Applicant: Radmedix, LLC. Device class: 2.

Clearance details

Applicant: Radmedix, LLC
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2019-12-04
Decision date: 2020-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dayton, OH, US

Download summary PDF View on FDA.gov ↗

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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.