Duns Number:650711448
Device Description: Anterior Imaging Module (AIM) is intended for screening, capture and storage of images of Anterior Imaging Module (AIM) is intended for screening, capture and storage of images of the Anterior part of eye and surrounding area, AIM camera is designed to be attached to any existing 3 step or 5 step slit lamps for true colour and monochrome imaging in visible spectrum of light. The camera of a smart phone is used to capture images of the eye. The device can be used at any time & over & over again by a trained user.
Catalog Number
3231680012
Brand Name
Remidio
Version/Model Number
AIM
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PJZ
Product Code Name
Camera, Ophthalmic, General-Use
Public Device Record Key
8b0cfcf0-7f30-4c56-acd9-a0a858ee726b
Public Version Date
April 08, 2022
Public Version Number
2
DI Record Publish Date
February 19, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |