FDA.reportPublic FDA data

Optina Fotys

Primary DI
00627987702149
Brand
Optina Fotys
Company
Optina Diagnostiques, Inc
Model
1.0.1
Published
2025-08-29
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
NFGDevice, Communications, Images, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFGDevice, Communications, Images, OphthalmicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627987702149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627987702149006279877021496279877021490627987702149

GMDN Terms#

Term, Definition table
TermDefinition
Medical image management systemA computerized image data management system designed to electronically receive, collect, store, and display a broad range of medical imaging/video data (non-dedicated), and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). The system consists of combined hardware (e.g., network switch, controller) and server/client software intended to relay image data from a broad range of imaging/audiovisual devices (e.g., endoscopic camera, ultrasound imaging system, radiography digital imaging system) to off-the-shelf devices [e.g., monitors, personal computers (PC’s)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203807979
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00627987702132Optina-4CMHRC-C1N2024-02-08
00627987702125Mydriatic Hyperspectral Retinal CameraMHRC-C12021-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260284390013Navilas® Laser System 577sOD-OS GmbHNFG2023-11-21
04987669200636Image filing software NAVIS-EXNIDEK CO.,LTD.NFG2023-06-12
08720892096401Cassini Guidance SystemCassini Technologies B.V.NFG2023-05-08
04549292182729CANON INC.CANON INC.NFG2020-10-16
00380659982682VERION™Alcon Laboratories, Inc.NFG2020-08-31
00380659982699VERION™Alcon Laboratories, Inc.NFG2020-08-31
00380659982705VERION™Alcon Laboratories, Inc.NFG2020-08-31
00380659982811VERION™Alcon Laboratories, Inc.NFG2020-08-31
04049471100020FORUM Viewer AppCarl Zeiss Meditec AGNFG2018-03-22
04987669100523Image filing softwareNIDEK CO.,LTD.NFG2016-08-26
04987669100554NON-MYDRIATIC AUTO FUNDUS CAMERANIDEK CO.,LTD.NFG2016-06-24
03596010589637INTEGRATION BROKERSmith & Nephew, Inc.NFG2016-04-12
03596010588371N/ASmith & Nephew, Inc.NFG2016-04-12
04049471094077VISUPAC 500Carl Zeiss Meditec AGNFG2016-01-15
03596010588388INTEGRATION BROKERSmith & Nephew, Inc.NFG2015-08-29