System, Image Management, Ophthalmic
Regulation 892.2050
2510(k)s in 12 months (53 all time)
0recalls in 12 months (14 all time)
13recalls that name a 510(k)
Top companies in NFJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Carl Zeiss Meditec, AG | 13 | 1 |
| Topcon Medical Systems, Inc. | 5 | 3 |
| Merge Healthcare, Inc. | 0 | 4 |
| Topcon Corp. | 3 | 0 |
| Bausch & Lomb Inc | 0 | 2 |
| Diagnos, Inc. | 1 | 1 |
| Haag-Streit AG | 1 | 1 |
| Huvitz Co., Ltd. | 2 | 0 |
| Konan Medical, Inc. | 2 | 0 |
| Nidek Co., Ltd. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 30, 2008 | K082364 | IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR Topcon Corp. | NFJ |
| Aug 31, 2007 | K071299 | IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP Digital Healthcare, Ltd. | NFJ |
| Nov 19, 2002 | K013694 | NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) Nidek, Inc. | NFJ |
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