DEVICE: IMAGEnet 6 (00850003069166)

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Device Record History
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Device Identifier (DI) Information
IMAGEnet 6
2.2.0
In Commercial Distribution

TOPCON HEALTHCARE SOLUTIONS, INC.
00850003069166
GS1

1
081155097 *Terms of Use
The IMAGEnet 6 ver. 2.2.0 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.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
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No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
38683 Camera application software
A 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OBO Tomography, Optical Coherence
HKI Camera, Ophthalmic, Ac-Powered
NFJ System, Image Management, Ophthalmic
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
13a160ce-437b-4322-bcac-b64d8e68ebc2
September 27, 2019
1
September 19, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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