The following data is part of a premarket notification filed by Amicas, Inc. with the FDA for Amicas Vision Series Pacs, Model 4.3.
| Device ID | K062477 |
| 510k Number | K062477 |
| Device Name: | AMICAS VISION SERIES PACS, MODEL 4.3 |
| Classification | System, Image Processing, Radiological |
| Applicant | AMICAS, INC. 20 GUEST ST. Boston, MA 02135 |
| Contact | Patrice Jc Nedelec |
| Correspondent | Patrice Jc Nedelec AMICAS, INC. 20 GUEST ST. Boston, MA 02135 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-24 |
| Decision Date | 2006-10-27 |
| Summary: | summary |