FDA.reportPublic FDA data

Optina-4C

Primary DI
00627987702132
Brand
Optina-4C
Company
Optina Diagnostiques, Inc
Model
MHRC-C1N
Device description
Mydriatic Hyperspectral Retinal Camera (MHRC-C1N)
Published
2024-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
HKICamera, Ophthalmic, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKICamera, Ophthalmic, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231230000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231230000Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.2023-12-05HKI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627987702132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627987702132006279877021326279877021320627987702132

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
00627987702149Optina Fotys1.0.12025-08-29
00627987702125Mydriatic Hyperspectral Retinal CameraMHRC-C12021-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00857253006101Phoenix ICON with Training KitPhoenix ClinicalHKI2026-04-03
00857253006118Phoenix ICON & FA Module with Training KitPhoenix ClinicalHKI2026-04-03
00857253006132Phoenix ICON GO with Training KitPhoenix ClinicalHKI2026-04-03
00857253006149Phoenix ICON GO & FA Module with Training Kit Phoenix ClinicalHKI2026-04-03
05713315011597RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
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05713315011931RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011948RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011962RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
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00860014304507OptainOptain Health, Inc.HKI2025-07-07
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00852788008071NeolightNEOLIGHT LLCHKI2025-01-26
10852788008085NeolightNEOLIGHT LLCHKI2025-01-26
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