SCANLY

Primary DI
07290017803029
Brand
SCANLY
Company
NOTAL VISION LTD
Model
01.02
Catalog number
910-0002
Device description
Home Monitoring Ophthalmic Optical Coherence Tomography (OCT) Imaging Device
Published
2025-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
SAXHome Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SAXHome Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging DeviceOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN230043000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN230043000Notal Vision Home Optical Coherence Tomography (OCT) SystemNotal Vision, Inc.2024-05-15SAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017803029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017803029072900178030297290017803029

GMDN Terms#

Term, Definition table
TermDefinition
Retinal optical coherence tomography systemAn assembly of devices that uses a broad-bandwidth light beam aimed into the eye for in vivo tomographic imaging and measurement of the retina, the retinal nerve fibre layer (its thickness), and optic disk in order to diagnose and manage retinal diseases. Reflected light is picked up by a detector that converts it into electrical signals using a computer and dedicated software, providing cross-sectional images of the retina or three-dimensional (3-D) volume scans. Optical coherence tomography (OCT) is used for visualizing the area/location of retinal-thickness abnormalities, macular holes or oedema, atrophy associated with degenerative diseases, glaucoma, and other retinal pathologies.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532596533
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017803012SCANLY 01.01910-00012024-06-18
07290017803005Foresee Homeā„¢V2901F0012021-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290017803012SCANLYNOTAL VISION LTDSAX2024-06-18