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 |