FDA.reportPublic FDA data

Harmony

Primary DI
00850003069180
Brand
Harmony
Company
TOPCON HEALTHCARE SOLUTIONS, INC.
Model
5.04.200
Device description
Harmony 5.04.200 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
Published
2020-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NFJSystem, Image Management, Ophthalmic

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182376000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182376000HarmonyTopcon Medical Systems, Inc.2018-09-28NFJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850003069180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003069180008500030691808500030691800850003069180

GMDN Terms#

Term, Definition table
TermDefinition
Camera application softwareA data program designed for use in, or together with, a camera (e.g., a digital camera or video recorder) so that it may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081155097
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003069036Synergy ODM4.10.5002020-03-04
00850003069081Synergy ODM4.09.5002020-03-02
00850003069135Glaucoma Module1.002021-02-26
00850003069265Harmony5.072021-02-26
00850003069296Harmony5.06.0032021-02-09
00850003069289Harmony5.06.0022021-02-04
00850003069128Harmony5.062021-01-29
00850003069234Harmony5.05.1022021-01-26
00850003069227Harmony5.05.1012021-01-19
00850003069197Harmony5.05.1002021-01-14
00850003069111Harmony5.052021-01-12
00850003069173Harmony5.04.1002020-12-09
00850003069302IMAGEnet 62.4.02020-12-09
00850003069012Harmony5.032020-12-08
00850003069098Harmony5.03.2002020-11-25
00850003069043Harmony5.042020-10-02
00850003069241IMAGEnet 62.3.02020-06-23
00850003069166IMAGEnet 62.2.02019-09-19
00850003069203IMAGEnet 62.2.12019-09-19
00850003069142IMAGEnet 62.1.12019-08-05

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