The following data is part of a premarket notification filed by Eos Imaging Inc. with the FDA for Stereos Workstation.
| Device ID | K130395 |
| 510k Number | K130395 |
| Device Name: | STEREOS WORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | EOS IMAGING INC. 555 THIRTEENTH ST, NW Washington, DC 20004 |
| Contact | John J Smith |
| Correspondent | John J Smith EOS IMAGING INC. 555 THIRTEENTH ST, NW Washington, DC 20004 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-15 |
| Decision Date | 2013-03-11 |
| Summary: | summary |