CANON INC.

Basic Information

• Brand Name: CANON INC.
• Primary DI: 04549292084696
• Version / Model: Ophthalmic Software Platform RX
• Company Name: CANON INC.
• Labeler DUNS: 690549662
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-12
• Public Version: 3
• Public Version Date: 2026-03-20
• Public Version Status: Update
• Public Device Record Key: ae898468-c69e-44dd-93a6-3a9990589c8f

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NFJ	System, Image Management, Ophthalmic	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52748	Posterior eye segment analyser software	An application software program designed for the collection, processing, and display of data resulting from the measurement/evaluation of various properties of the posterior eye segment performed with an anterior eye segment analyser. It may be installed in the integrated analyser computer and/or an off-the-shelf computer (e.g., desktop, laptop).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04549292084696	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K173689	000