MAIA - S-MAIA is intended for measuring macular - CENTERVUE SPA

Duns Number:338702316

Device Description: S-MAIA is intended for measuring macular sensitivity, fixation stability and the locus of 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.

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More Product Details

Catalog Number

ACMASME002

Brand Name

MAIA

Version/Model Number

S-MAIA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K153181

Product Code Details

Product Code

HPT

Product Code Name

Perimeter, Automatic, Ac-Powered

Device Record Status

Public Device Record Key

7b5d9ca7-9a8f-4b28-a1f1-f6405ef7467d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 03, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CENTERVUE SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 7