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FDA 510(k)

MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System

K-Number: K193637 · 2020-01-28

ApplicantCompania Mexicana DE Radiologia Cgr, S.A. DE C.V.
Decision Date2020-01-28
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System is a medical device manufactured by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.. It received FDA 510(k) clearance on 2020-01-28 under approval number K193637. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System?

MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System is a medical device that received FDA 510(k) clearance on 2020-01-28. It is manufactured by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.. The 510(k) number is K193637.

When was MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System approved by the FDA?

MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System received FDA 510(k) clearance on 2020-01-28, under approval number K193637.

What company makes MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System?

MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System is manufactured by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V..

What is the FDA product code for MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System?

The FDA product code for MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System is KPR.

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Other Devices by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.

K161518PACS CORE/ENCORE K182134ARiX RAD Radiographic System

Related Devices (Code: KPR)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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