Clearance Summary
MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System received FDA 510(k) clearance under submission number K193637, sponsored by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-01-28.
- Submission: K193637
- Applicant / Sponsor: Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2020-01-28
Classification & Regulation
This clearance is catalogued under FDA product code KPR and 21 CFR 892.1680, within the Radiology review panel as a Class II device.