MAIA
Basic Information
- Brand Name
- MAIA
- Primary DI
- 08053677040055
- Version / Model
- S-MAIA
- Catalog Number
- ACMASME002
- Company Name
- CENTERVUE SPA
- Labeler DUNS
- 338702316
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-03
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 7b5d9ca7-9a8f-4b28-a1f1-f6405ef7467d
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HPT | Perimeter, Automatic, Ac-Powered | Ophthalmic | 886.1605 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16918 | Perimeter, automatic | A mains electricity (AC-powered), automatically operated, diagnostic, ophthalmic instrument intended for assessing the extent of the patient's peripheral visual field. Small luminous points (spots) are automatically displayed in various random positions and patient response is automatically recorded. The print-out (chart) then shows the resulting curve of the visual field. Such types include Humphrey perimeters. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08053677040055 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153181 | 000 |