The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Bone Suppression Software.
| Device ID | K133442 |
| 510k Number | K133442 |
| Device Name: | BONE SUPPRESSION SOFTWARE |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | CARESTREAM HEALTH, INC. 150 VERONA STREET Rochester, NY 14608 |
| Contact | Carolyn Wagner |
| Correspondent | Carolyn Wagner 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 | 2013-11-12 |
| Decision Date | 2014-03-11 |
| Summary: | summary |