FDA.reportPublic FDA data

Verily Numetric Retinal Camera

Primary DI
00860000249584
Brand
Verily Numetric Retinal Camera
Company
VERILY LIFE SCIENCES LLC
Model
VNRC -101
Device description
Verily Numetric Retinal Camera is a non-contact, high resolution digital imaging device which issuitable for photographing, displaying and storing images of the retina segment of the eye to beevaluated under non-mydriatic conditions.Verily Numetric Retinal Camera is indicated for in-vivo viewing of the posterior segment of the eye.The images are intended for use as an aid to clinicians in the evaluation, diagnosis, anddocumentation of ocular health.
Published
2025-02-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K242508000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242508000Verily Numetric Retinal CameraVerily Life Sciences, LLC2024-12-09HKI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860000249584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860000249584008600002495848600002495840860000249584

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

Contacts#

Phone, Email table
PhoneEmail
855-629-0918retinalcamera-support@verily.com

Regulatory Flags#

DUNS number
080061720
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860000249543Verily Retinal CameraVRC-1002023-05-24
00860000249515Onduo SW00022020-08-25
00860000249522OnduoSW00032020-08-25
00860000249539OnduoSW00042020-08-25
08600002495013Onduo SW00022020-08-25
08600002495020OnduoSW00032020-08-25
08600002495037OnduoSW00042020-08-25

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