FDA.reportPublic FDA data

IMAGEnet 6

Primary DI
00850003069302
Brand
IMAGEnet 6
Company
TOPCON HEALTHCARE SOLUTIONS, INC.
Model
2.4.0
Device description
The IMAGEnet 6 ver. 2.4.0 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices.
Published
2020-12-09
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
HKICamera, Ophthalmic, Ac-Powered
NFJSystem, Image Management, Ophthalmic
OBOTomography, Optical Coherence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKICamera, Ophthalmic, Ac-PoweredOphthalmic2
NFJSystem, Image Management, OphthalmicRadiology2
OBOTomography, Optical CoherenceOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850003069302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003069302008500030693028500030693020850003069302

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
00850003069180Harmony5.04.2002020-12-22
00850003069173Harmony5.04.1002020-12-09
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

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04059237000235SPECTRALISHeidelberg Engineering GmbHOBO2025-03-24
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