K081836 is an FDA 510(k) clearance for the CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Carestream Health, Inc. (Rochester, US). The FDA issued a Cleared decision on July 30, 2008, 30 days after receiving the submission on June 30, 2008.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K081836 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2008 |
| Decision Date | July 30, 2008 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | KPR — System, X-ray, Stationary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |