The following data is part of a premarket notification filed by Topcon Corp. with the FDA for Imagenet Professional Pc Software System Or Imagenet Professional, Or Imagenet Pro, Or Digital Imaging Software For.
| Device ID | K082364 |
| 510k Number | K082364 |
| Device Name: | IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR |
| Classification | System, Image Management, Ophthalmic |
| Applicant | TOPCON CORP. 310 TERRACE AVENUE SUITE 201 Cincinnati, OH 45220 |
| Contact | Barbara S Fant, Pharm.d. |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-08-18 |
| Decision Date | 2008-09-30 |
| Summary: | summary |