The following data is part of a premarket notification filed by Avreo, Inc. with the FDA for Avreo Interworks System.
| Device ID | K141556 |
| 510k Number | K141556 |
| Device Name: | AVREO INTERWORKS SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | AVREO, INC. 4050 Azalea Dr N Charleston, SC 29405 |
| Contact | Alison Mckee |
| Correspondent | Alison Mckee AVREO, INC. 4050 Azalea Dr N Charleston, SC 29405 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-12 |
| Decision Date | 2014-07-02 |
| Summary: | summary |