FDA 510(k)

MRH ALFA 放射線システム、MRH II 放射線システム、MRH IIE 放射線システム

K番号: K193637 · 2020-01-28

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

決定日2020-01-28

製品コードKPR

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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

よくある質問

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. The listed applicant is Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.. The 510(k) number is K193637.

When did MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System receive FDA 510(k) clearance?

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

Who is the listed applicant for MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System?

The FDA 510(k) record lists Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.

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.

申請者としてCompania Mexicana DE Radiologia Cgr, S.A. DE C.V.を記載するその他の記録

K182134ARiX RAD 放射線システム K161518PACS コア/エンコレ

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