FDA.reportPublic FDA data

AMA Optics Digital Vision Test

Primary DI
G506DG010
Brand
AMA Optics Digital Vision Test
Company
AMA Optics, Inc.
Model
DiagnosticGame
Catalog number
DG01
Device description
A digital vision testing system intended as an aid in assessment of visual function in patients. The software delivers algorithms that utilize a visual display which may be a tablet, smart phone, a computer screen, etc.
Published
2023-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QTODigital Visual Acuity Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QTODigital Visual Acuity TestOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G506DG010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vision self-testing softwareA software as a medical device (SaMD) application intended to be used by a patient for self-testing of visual function under consultation of a clinician (e.g., ophthalmologist). It provides on-screen images (e.g., shapes) whereby visual function can be tested over time (e.g., to monitor macular degeneration). It is intended to store and allow communication of the results with healthcare professionals.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
192827462
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G506PH010AMA Optics Panoramic PinholePH-01-PHPH012023-09-01
G506HOLDER010AMA Optics Lens HolderLH-01HOLDER012023-08-01
G506LY010AMA Optics LanyardLY-01LY012023-08-01
G506RAM01160AMA Optics CordCACL-CORDRAM01162023-08-01
G506RAM0280 AMA Optics CordCALC-CORDRAM0282023-08-01
G506RAM03160AMA Optics CordCALC-CORDRAM03162023-08-01
G506NC010NeuroColorCOLOR-01NC012023-09-30
G506BAM010AMA Optics Brightness Acuity MeterGLARE-01-DEUCEBAM012023-09-01
G506MACDX010MacDxMACDX-01-PROMACDX012023-09-01
G506PHLC010AMA Optics Pinhole ClipPHC-01-PHPHLC012023-09-01
G506PHLC020RAM Panoramic Pinhole ClipPHC-O1-PPHPHL022023-09-01
G506RAM030AMA Optics RetinometerRAM-03-PRAM032023-09-01
G506RAM040AMA Optics RetinometerRAM-04-PXLRAM042023-09-01
G506RAM050AMA Optics ETDRSRAM ETDRSRAM052023-09-01
G506RAM20AMA Optics RetinometerRAM-01-ORAM022023-09-01
G506FRAME010RAM Testing FramesFrames-01FRAME012023-08-01
G506AMBYO010AMA Optics AmblyometerAmblyo-01AMBLYO012023-08-01
G506CCCLC0AMA Optics OccluderO-CLIPOCCLC2023-08-01
G506LVA010AMA Optics Vision AdaptorLVA-01LVA012023-08-01
G506OCCLM0AMA Optics OccluderO-MAGNETICOCCLM2023-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850067216025Manifold Vision MeterAdaptive Sensory Technology, Inc.QTO2026-05-21
00850067216032Manifold Vision MeterAdaptive Sensory Technology, Inc.QTO2026-05-21
00850067216001Manifold Vision MeterAdaptive Sensory Technology, Inc.QTO2025-10-07
00850067216018Manifold Vision MeterAdaptive Sensory Technology, Inc.QTO2025-10-07
00850040295818OCULUS Easyfield VRThe Hilsinger Company Parent LLCQTO2023-12-25
07290018993408MyRx Visual Acuity 6 OVER 6 VISION LTDQTO2023-08-30
00853569007146PalmScan VS2000Micro Medical Devices, Inc.QTO2023-08-16
00850038376000VDAPVisibly, Inc.QTO2022-09-19
00850040295238M&S Technologies ACUITYexThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295566M&S Technologies Smart System® 20/20The Hilsinger Company Parent LLCQTO2022-07-06
00850040295573M&S Technologies Smart System® PC-PlusThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295597M&S Technologies Smart System® 20/20 TabletThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295016M&S Technologies VisiChart® Acuity ChartThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295122M&S Technologies Smart System® Virtual Reality Headset SystemThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295139M&S Technologies Clinical Trial Suite®The Hilsinger Company Parent LLCQTO2022-07-06
00850040295214M&S Technologies Melbourne Rapid Fields Device In-ClinicThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295351M&S Technologies ACUITYexThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295559M&S Technologies Smart System® StandardThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295047M&S Technologies Smart System® 20/20The Hilsinger Company Parent LLCQTO2022-07-06
00850040295191M&S Technologies Smart System® PC-PlusThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295108M&S Technologies Smart System® 20/20 TabletThe Hilsinger Company Parent LLCQTO2022-07-06