MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System— 510(k) K193637

Name: FDA 510(k) clearance K193637
Creator: U.S. Food and Drug Administration
Published: 2020-01-28

Substantially Equivalent

Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.

FDA 510(k) clearance K193637 for MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System, Substantially Equivalent on 2020-01-28. Applicant: Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.. Device class: 2.

Clearance details

Applicant: Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2019-12-27
Decision date: 2020-01-28
Decision: Substantially Equivalent
Clearance type: Special
Location: El Marques, Queretaro, MX

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.