Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Miegmbh — 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) |
|---|---|---|---|---|---|
| K201807 | ANCORIS | Miegmbh | 2020-08-27 | 57 | 0 |
| K130269 | ECAT SCINTRON PET | Miegmbh | 2013-04-19 | 74 | 0 |
| K101768 | MIE SCINTRON GAMMA CAMERA SYSTEMS | Miegmbh | 2010-10-05 | 104 | 0 |
| K101013 | MODIFICATION TO SCINTRON IV | Miegmbh | 2010-06-07 | 56 | 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