The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Eclipse Ii With Smart Noise Cancellation.
| Device ID | K213307 |
| 510k Number | K213307 |
| Device Name: | Eclipse II With Smart Noise Cancellation |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Carestream Health, Inc. 150 Verona St Rochester, NY 14608 |
| Contact | Gina Maiolo |
| Correspondent | Gina Maiolo Carestream Health, Inc. 150 Verona St 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 | 2021-10-04 |
| Decision Date | 2022-01-14 |