510(k) K193637
K193637 is an FDA 510(k) premarket notification submitted by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. for the device "MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System". The FDA issued a decision of Substantially Equivalent on Jan 28, 2020. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 28, 2020
- Date Received
- Dec 27, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type
- 510(k)