Device
MAIA is a peripheral vision analyser, intended for measuring retinal sensitivity, fixation stability and locus fixation as well as to acquire and review retinal images with or with...
Manufacturer
CENTERVUE SPA
CENTERVUE SPA
Model: MAIA3
Catalog: AHMACME001
DI: 08053677040130
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
MAIA is a peripheral vision analyser, intended for measuring retinal sensitivity, fixation stability and locus fixation as well as to acquire and review retinal images with or without a mydriatic agent and for their review.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a05d8311-26a0-4c8d-a8f9-c0e208c18c40
Distribution Status:
In Commercial Distribution
DUNS Number:
338702316
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08053677040130
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 16918
Name: Perimeter, automatic
Definition:
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.
FDA Product Codes
MYC
Ophthalmoscope, Laser, Scanning
Premarket Submissions
Submission Number:
K243504
Supplement Number:
000