The following data is part of a premarket notification filed by Carestream Health, Inc with the FDA for Eclipse Ii.
| Device ID | K180809 |
| 510k Number | K180809 |
| Device Name: | Eclipse II |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Carestream Health, Inc 150 Verona Street Rochester, NY 14608 |
| Contact | Diane Koetter |
| Correspondent | Diane Koetter Carestream Health, Inc 150 Verona Street Rochester, NY 14608 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-28 |
| Decision Date | 2018-06-21 |
| Summary: | summary |