MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System
FDA 510(k) clearance K193637 · decided 2020-01-28
Clearance details
- K-number
- K193637
- Device name
- MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System
- Applicant
- Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.
- Decision
- Substantially Equivalent
- Date received
- 2019-12-27
- Decision date
- 2020-01-28
- Days to decision
- 32 days
- Clearance type
- Special
- Product code
- KPR
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- El Marques, Queretaro, MX
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.