AMA Optics Retinometer RAM04

GUDID G506RAM040

An ophthalmic retro-illuminated chart with adjustable brightness that is printed with various symbols (letters, numbers, pictures, dots) intended to be used for testing visual acuity (e.g., Snellen chart) for routine visual function examination (e.g., preoperative visual acuity prediction and postoperative visual acuity recovery assessment for cataract, glaucoma, retinopathy, amblyopia, etc.). The charts are exchangeable.

AMA Optics, Inc.

Vision testing/training chart
Primary Device IDG506RAM040
NIH Device Record Key9eb7a870-1bf7-43c6-a5bf-0d1394e9e270
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMA Optics Retinometer
Version Model NumberRAM-04-PXL
Catalog NumberRAM04
Company DUNS192827462
Company NameAMA Optics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG506RAM040 [Primary]

FDA Product Code

HOXChart, Visual Acuity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-11
Device Publish Date2023-09-01

On-Brand Devices [AMA Optics Retinometer]

G506RAM010An ophthalmic retro-illuminated chart printed with various symbols (letters, numbers, pictures,
G506RAM20An ophthalmic retro-illuminated chart printed with various symbols (letters, numbers, pictures,
G506RAM040An ophthalmic retro-illuminated chart with adjustable brightness that is printed with various sy
G506RAM030An ophthalmic retro-illuminated chart with adjustable brightness that is printed with various sy

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.