Medimaging Integrated Solution, Inc (Miis): FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Medimaging Integrated Solution, Inc (Miis)” (first 2017, latest 2025), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 186 days. Since 2017 the median was 186 days, against 148 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 232 |
| 2018 | 0 | — |
| 2019 | 1 | 406 |
| 2020 | 1 | 57 |
| 2021 | 0 | — |
| 2022 | 1 | 186 |
| 2023 | 1 | 280 |
| 2024 | 1 | 126 |
| 2025 | 1 | 85 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medimaging Integrated Solution, Inc (Miis) took a median 186 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 148 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 2 | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
| HKX | Tonometer, Ac-Powered | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
Review panels
Most recent Medimaging Integrated Solution, Inc (Miis) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) | HRX | 2025-12-23 | 85 |
| K234113 | MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box | EOQ | 2024-05-01 | 126 |
| K223926 | VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box | FAJ | 2023-10-06 | 280 |
| K214050 | ENT Nasopharyngoscope and Accessories | EOB | 2022-07-01 | 186 |
| K193188 | MiiS Horus Eye Anterior Camera | HJO | 2020-01-14 | 57 |
| K181260 | MiiS Horus Scope DPT 100 | HKX | 2019-06-21 | 406 |
| K170470 | Digital Eye Anterior Camera | HJO | 2017-10-06 | 232 |
Recalls
openFDA lists no recalls under a recalling firm named Medimaging Integrated Solution, Inc (Miis).
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medimaging Integrated Solution, Inc. (1 510(k)s)
- Medimaging Integrated Solutions, Inc. (Miis) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medimaging Integrated Solution, Inc (Miis)?
FDA lists 7 510(k) clearances under the applicant name “Medimaging Integrated Solution, Inc (Miis)” (first 2017, latest 2025), across 6 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medimaging Integrated Solution, Inc (Miis)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medimaging Integrated Solution, Inc (Miis) is 186 days. Since 2017: 186 days, versus 148 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medimaging Integrated Solution, Inc (Miis)?
The most frequent FDA product codes under this applicant name are HJO (Biomicroscope, Slit-Lamp, Ac-Powered, 2); EOB (Nasopharyngoscope (Flexible Or Rigid), 1); EOQ (Bronchoscope (Flexible Or Rigid), 1).
Next steps
- See all 7 Medimaging Integrated Solution, Inc (Miis) clearances with predicates and recalls
- Run predicate analysis for product code HJO, Medimaging Integrated Solution, Inc (Miis)'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.