Maia
S-MAIA is intended for measuring macular sensitivity, fixation stability and the locus of fixation, as well as providing infrared retinal imaging. It contains a reference database that is a…
S-MAIA is intended for measuring macular sensitivity, fixation stability and the locus of fixation, as well as providing infrared retinal imaging. It contains a reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects. The S-MAIA allows also the measurement of macular sensitivity and fixation under scotopic (or low light) background conditions, in addition to the standard measurement performed in mesopic conditions. Both a scotopic red (stimulus central wavelength 627 nm) and scotopic blue (stimulus central wavelength 550 nm) test modalities are available with the Scotopic model. Both modalities employ specific luminance scales and do not allow comparison with reference normal values.
Who Else Makes It
Concentrated in Chongqing (4), Jiangsu (2), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Chongqing Sunkingdom Medical Instrument Co., Ltd. | Chongqing | Chongqing | Manufacturer | 11 |
| Visuscience Meditech Co., Ltd. | Wuxi | Jiangsu | Specification developer | 9 |
| Main Meditech Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 5 |
| Chongqing Kanghua Ruiming S&T Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 3 |
| Chongqing SS Medical Equipments Co., Ltd. | Chongqing | Chongqing | Manufacturer | 3 |
Record
| Listed by | Centervue, Italy |
|---|---|
| FDA product code | HPT |
| Device type | Perimeter, Automatic, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1605 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K153181 |
| Record published | 2016-08-03 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S-MAIA | In distribution | |
| MAIA | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Perimeter | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 7 |
| Perimeter, Automatic, Ac-Powered | Chongqing Kanghuaruiming S&T Co., Ltd.. | 7 |
| Automated Perimeter | Optopol Technology SP Z O O | 5 |
| Virtual Field | Virtual Field, Inc | 4 |
| Humphrey Field Analyzer 3 (HFA3) | Carl Zeiss Meditec Inc | 4 |
| Carrot | Virtual Field, Inc | 3 |
| Eli Ezer | U.S. Ophthalmic, L.L.C. | 2 |
| SYL | Chongqing SS Medical Equipments Co., Ltd. | 2 |
| VisionOne | PeriVision SA | 2 |
| RetinaLogik | Retinalogik Inc. | 2 |
| Medmont Automated Perimeter DAC | Medmont International PTY Ltd | 1 |
| Foresee Home™ | Notal Vision Ltd. | 1 |
Showing 12 of 34. All products under Perimeter, Automatic, Ac-Powered
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.