K132438 is an FDA 510(k) clearance for the IMAGENET 5 PC SOFTWARE SYSTEM. This device is classified as a System, Image Management, Ophthalmic (Class II - Special Controls, product code NFJ).
Submitted by Topcon Medical Systems, Inc. (North Reading, US). The FDA issued a Cleared decision on October 17, 2013, 73 days after receiving the submission on August 5, 2013.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K132438 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2013 |
| Decision Date | October 17, 2013 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | NFJ — System, Image Management, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |