# K193637: MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System

- Pathway: 510(k) (Special)
- Applicant: Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.
- Decided: Jan 28, 2020 after 32 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K981556 (1998). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182134: ARiX RAD Radiographic System, Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. (2018) Summary page 5.

## Indications for use
1. The MRH ALFA system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is designed to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the MRH ALFA radiographic system. The acquisition system comes as a separate system. The MRH ALFA system is not intended for use in mammography, fluoroscopy or angiography. The MRH ALFA system is intended for adults and pediatric patients. The pediatric population is as follow: • Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.) • Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.) 2. The MRH II system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is designed to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the MRH II radiographic system. The acquisition system comes as a separate system. The MRH II system is not intended for use in mammography, fluoroscopy or angiography. The MRH II system is intended for adults and pediatric patients. The pediatric population is as follow: • Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.) • Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.) 3. The MRH IIE system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is designed to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the MRH IIE radiographic system. The acquisition system comes as a separate system. The MRH IIE system is not intended for use in mammography, fluoroscopy or angiography. The MRH IIE system is intended for adults and pediatric patients. The pediatric population is as follow: • Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.) • Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)

Source page: https://510kreport.com/device/K193637
Methodology: https://510kreport.com/methodology