The following data is part of a premarket notification filed by Carestream Health,inc. with the FDA for Carestream Dr Long Length Imaging System For Dr 7500 System.
| Device ID | K081836 |
| 510k Number | K081836 |
| Device Name: | CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM |
| Classification | System, X-ray, Stationary |
| Applicant | CARESTREAM HEALTH,INC. 150 VERONA STREET Rochester, NY 14608 |
| Contact | Christine Ehmann |
| Correspondent | Christine Ehmann CARESTREAM HEALTH,INC. 150 VERONA STREET Rochester, NY 14608 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-30 |
| Decision Date | 2008-07-30 |