FDA.reportPublic FDA data

Mydriatic Hyperspectral Retinal Camera

Primary DI
00627987702125
Brand
Mydriatic Hyperspectral Retinal Camera
Company
Optina Diagnostiques, Inc
Model
MHRC-C1
Device description
Mydriatic Hyperspectral Retinal Camera (MHRC-C1)
Published
2021-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HKICamera, Ophthalmic, Ac-Powered
NFJSystem, Image Management, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKICamera, Ophthalmic, Ac-PoweredOphthalmic2
NFJSystem, Image Management, OphthalmicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200254000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200254000Mydriatic Hyperspectral Retinal Camera (MHRC-C1)Optina Diagnostics2020-04-27HKI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627987702125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627987702125006279877021256279877021250627987702125

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic fundus cameraAn electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203807979
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00627987702132Optina-4CMHRC-C1N2024-02-08
00627987702149Optina Fotys1.0.12025-08-29

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