The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektascan Imagelink Ultrasound System.
| Device ID | K914728 |
| 510k Number | K914728 |
| Device Name: | KODAK EKTASCAN IMAGELINK ULTRASOUND SYSTEM |
| Classification | Device, Digital Image Storage, Radiological |
| Applicant | EASTMAN KODAK COMPANY 100 CARLSON RD. Rochester, NY 14610 |
| Contact | Norman H Geil |
| Correspondent | Norman H Geil EASTMAN KODAK COMPANY 100 CARLSON RD. Rochester, NY 14610 |
| Product Code | LMB |
| CFR Regulation Number | 892.2010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-21 |
| Decision Date | 1992-03-02 |