Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medphoton GmbH · 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) |
|---|---|---|---|---|---|
| K234067 | ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mo | Medphoton GmbH | 2025-03-28 | 462 | 0 |
| K203281 | Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, | Medphoton GmbH | 2020-12-22 | 46 | 0 |
| K191267 | ImagingRing System on Rails | Medphoton GmbH | 2019-08-01 | 83 | 0 |
| K161400 | ImagingRing System | Medphoton GmbH | 2016-12-08 | 202 | 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