Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medimaging Integrated Solution, Inc (Miis) — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
186 daysmedian FDA review time
406 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Displ | Medimaging Integrated Solution, Inc (Miis) | 2025-12-23 | 85 | 0 |
| K234113 | MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System | Medimaging Integrated Solution, Inc (Miis) | 2024-05-01 | 126 | 0 |
| K223926 | VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, an | Medimaging Integrated Solution, Inc (Miis) | 2023-10-06 | 280 | 0 |
| K214050 | ENT Nasopharyngoscope and Accessories | Medimaging Integrated Solution, Inc (Miis) | 2022-07-01 | 186 | 0 |
| K193188 | MiiS Horus Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | 2020-01-14 | 57 | 0 |
| K181260 | MiiS Horus Scope DPT 100 | Medimaging Integrated Solution, Inc (Miis) | 2019-06-21 | 406 | 0 |
| K170470 | Digital Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | 2017-10-06 | 232 | 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