The following data is part of a premarket notification filed by Eos Imaging with the FDA for Eos.
| Device ID | K120721 |
| 510k Number | K120721 |
| Device Name: | EOS |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | EOS IMAGING 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | John J Smith |
| Correspondent | John J Smith EOS IMAGING 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-08 |
| Decision Date | 2012-04-06 |
| Summary: | summary |