The following data is part of a premarket notification filed by Eos Imaging with the FDA for Stereos Workstation.
| Device ID | K113344 |
| 510k Number | K113344 |
| Device Name: | STEREOS WORKSTATION |
| Classification | System, Image Processing, Radiological |
| 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 | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-14 |
| Decision Date | 2012-11-16 |
| Summary: | summary |