Panels › Ophthalmic › Product code HKI · Class 2
Camera, Ophthalmic, Ac-Powered
Regulation 886.1120
3510(k)s in 12 months (157 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in HKI
| Company | 510(k)s | Recalls |
|---|---|---|
| Canon USA, Inc. | 19 | 0 |
| Kowa Co. , Ltd. | 14 | 0 |
| Clarity Medical Systems | 4 | 3 |
| Nidek Co., Ltd. | 5 | 2 |
| Topcon Corp. | 7 | 0 |
| Optomed OY | 5 | 0 |
| Nidek Technologies Srl | 4 | 0 |
| Tearscience, Inc. | 4 | 0 |
| Kowa Optimed, Inc. | 3 | 0 |
| Medivision Medical Imaging, Ltd. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 22, 1985 | K844898 | CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM Canon USA, Inc. | HKI |
| Oct 5, 1984 | K843021 | CANON 60 FUNDUS CAMERA CF-60U Canon USA, Inc. | HKI |
| Mar 2, 1984 | K833694 | TEXAS BIO SCAN Texas Bio Scan | HKI |
| Feb 24, 1983 | K822991 | AO DOCUSTAR(MMIRO) FUNDUS CAMERA Warner-Lambert Co. | HKI |
| Jan 5, 1983 | K823719 | AML (ANGLE MAGNIFYING LENS Nikon, Inc. | HKI |
| Jan 5, 1983 | K822908 | COHERENT FUNDUSL RETINAL CAMERA Coherent Medical Division | HKI |
| Jun 3, 1977 | K770888 | POMERANTZEFF EQUATOR PLUS CAMERA Medical Instrument Research Assoc., Inc. | HKI |
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