FDA.reportPublic FDA data

NeuroColor

Primary DI
G506NC010
Brand
NeuroColor
Company
AMA Optics, Inc.
Model
COLOR-01
Catalog number
NC01
Device description
An ophthalmic device that consists of various coloured materials, e.g., coloured yarns or colour vision plates (multicoloured plates which patients with colour vision deficiency would perceive as being of one colour), used for evaluating colour vision.
Published
2023-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HITTester, Color Vision

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HITTester, Color VisionOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G506NC010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Colour discrimination testerAn ophthalmic device that consists of various coloured materials, e.g., coloured yarns or colour vision plates (multicoloured plates which patients with colour vision deficiency would perceive as being of one colour), used for evaluating colour vision.

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
G506DG010AMA Optics Digital Vision TestDiagnosticGameDG012023-08-01
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
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
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00860010709795Virtual Eye SoftwareVirtual Vision HealthHIT2024-12-16
00860010709788Virtual Eye SoftwareVirtual Vision HealthHIT2024-11-27
00860010709757Virtual Eye SoftwareVirtual Vision HealthHIT2024-08-20
00860010709740Virtual Eye SoftwareVirtual Vision HealthHIT2024-05-07
00860010709733Virtual Eye SoftwareVirtual Vision HealthHIT2024-02-27
00860001720433Virtual FieldVirtual Field, Inc.HIT2023-11-08
04582275270068NAKONAN MEDICAL USA, INC.HIT2023-06-15
00860001720402Virtual FieldVirtual Field, Inc.HIT2023-01-23
00860001720426Virtual FieldVirtual Field, Inc.HIT2023-01-23
00860001720419Virtual FieldVirtual Field, Inc.HIT2023-01-23
04049584014795C-QuantOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHIT2022-12-07
06971821401038Computerized vision testerNingbo Ming Sing Optical R & D Co., Ltd.HIT2020-08-20
06971821401021COMPUTERIZED VISION TESTERNingbo Ming Sing Optical R & D Co., Ltd.HIT2019-12-02