Device, Digital Image Storage, Radiological
Regulation 892.2010
0510(k)s in 12 months (55 all time)
0recalls in 12 months (19 all time)
4recalls that name a 510(k)
Top companies in LMB
| Company | 510(k)s | Recalls |
|---|---|---|
| Merge Healthcare, Inc. | 0 | 5 |
| Eastman Kodak Company | 4 | 0 |
| Camtronics, Ltd. | 3 | 0 |
| Eigen | 3 | 0 |
| Olympus America, Inc. | 1 | 2 |
| Stryker Imaging | 0 | 3 |
| Andros Analyzers, Inc. | 2 | 0 |
| Base Ten Systems, Inc. | 2 | 0 |
| Ge Healthcare It | 0 | 2 |
| O Tech, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 27, 1986 | K863286 | ERS SYSTEM General Electric Co. | LMB |
| Oct 27, 1986 | K862842 | ADVANCED NUCLEAR COMPUTER Advanced Nuclear Imaging Corp. | LMB |
| Jan 22, 1985 | K844132 | MEDIVISION SERIES 5000 FLUOROSCOPIC DIGITAL IMAGER Sigma Teleproducts, Inc. | LMB |
| Dec 17, 1984 | K843349 | ND3100 VIDEO IMAGER Nuclear Data, Inc. | LMB |
| Nov 21, 1983 | K833525 | CEMAX-1000 Contour Medical Systems, Inc. | LMB |
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