The following data is part of a premarket notification filed by Kodak Health Imaging Systems, Inc. with the FDA for Kodak Xls 8600 (ps).
| Device ID | K951948 |
| 510k Number | K951948 |
| Device Name: | KODAK XLS 8600 (PS) |
| Classification | Camera, Multi Format, Radiological |
| Applicant | KODAK HEALTH IMAGING SYSTEMS, INC. 18325 WATERVIEW PKWY. Dallas, TX 75252 |
| Contact | Carl Alletto |
| Correspondent | Carl Alletto KODAK HEALTH IMAGING SYSTEMS, INC. 18325 WATERVIEW PKWY. Dallas, TX 75252 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-26 |
| Decision Date | 1995-09-13 |