FDA.reportPublic FDA data

OPTOS ADVANCE

Primary DI
05057056905709
Brand
OPTOS ADVANCE
Company
OPTOS PUBLIC LIMITED COMPANY
Model
S90570
Published
2016-05-27
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
NFJSystem, Image Management, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFJSystem, Image Management, OphthalmicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05057056905709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05057056905709050570569057095057056905709

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system application softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. It is designed specifically for use within radiology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
346013337
Device count
1
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05057056003856Optos OCT/SLOOCT0003852016-11-23
05057056010212Panoramic OphthalmoscopeP200A10212016-05-27
05057056100210Panoramic OphthalmoscopeP200CA100212016-05-27
05057056100920Panoramic Opthalmoscope200TxA100922016-11-23
05057056106007Panoramic OphthalmoscopeP200TA106002016-05-27
05057056106397OPTOS ADVANCE IMAGE SERVERA106392016-05-27
05057056106502Panoramic OphthalmoscopeP200DTxA106502016-05-27
05057056106885OPTOS ADVANCE IMAGE SERVERA106882016-05-27
05057056107004OCT OphthalmoscopeP200TEA107002018-04-02
05057056108049Optos Arm RestA10804A108042022-12-08
05057056107509OCT Ophthalmoscope P200TxEA107502019-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08053677040512iCare ALTIUS CWCENTERVUE SPANFJ2026-04-29
06430078740296Harmony Referral SystemTopcon Healthcare Solutions EMEA OyNFJ2026-01-28
08800019600794Huvitz Integrated Image Server HIIS-1Huvitz Co., Ltd.NFJ2025-08-14
06430078740272Harmony Referral SystemTopcon Healthcare Solutions EMEA OyNFJ2025-08-07
00850003069357HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
00850003069432HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
00850003069500HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
00850003069517HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
00850003069524HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
00850003069531HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
00850003069548HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
00850003069555HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
00850003069562HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
00850003069579HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
00850003069586HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
00850003069593HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
G20910Continuum PACSIntegrated Ophthalmic Systems, Inc.NFJ2024-08-19
04260648620053AshvinsMedicalCommunications GmbHNFJ2024-07-09
04260648620060Ashvins variant HEYEX 2 / HEYEX PACSMedicalCommunications GmbHNFJ2024-07-09
04260648620077Ashvins variant Ashvins Diagnostic WorkstationMedicalCommunications GmbHNFJ2024-07-09
04260648620084Ashvins variant Ashvins Diagnostic WorkstationMedicalCommunications GmbHNFJ2024-07-09
04049539070302CALLISTO eye SoftwareCarl Zeiss Meditec AGNFJ2024-06-06
G62650OVision Imaging SystemOPHTHALMIC LABS INCNFJ2024-04-11
00732094223910Welch Allyn, Inc.WELCH ALLYN, INC.NFJ2023-08-24
06430078740005Harmony Referral SystemTopcon Healthcare Solutions EMEA OyNFJ2023-08-22
04987669101568Scanning Laser OphthalmoscopeNIDEK CO.,LTD.NFJ2023-06-12
04987669200636Image filing software NAVIS-EXNIDEK CO.,LTD.NFJ2023-06-12
04987669200773AL-Scan Viewer for NAVIS-EXNIDEK CO.,LTD.NFJ2023-06-12
04987669607350CEM Viewer for NAVIS-EXNIDEK CO.,LTD.NFJ2023-06-12
04049471070330FORUMCarl Zeiss Meditec AGNFJ2023-04-14