Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K193637 | MRH ALFA Radiographic System, MRH II Radiographic System, MR | Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. | 2020-01-28 | 32 | 0 |
| K182134 | ARiX RAD Radiographic System | Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. | 2018-11-26 | 112 | 0 |
| K161518 | PACS CORE/ENCORE | Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. | 2016-08-17 | 76 | 0 |
| K123650 | ARIX RAD ACQUISITION CONSOLE | Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. | 2013-02-20 | 85 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda