The following data is part of a premarket notification filed by Amicas, Inc. with the FDA for Amicas Light Beam Workstation, Model 1.0.
| Device ID | K022970 |
| 510k Number | K022970 |
| Device Name: | AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | AMICAS, INC. 20 GUEST ST. Brighton, MA 02135 |
| Contact | Patrice Nedelec |
| Correspondent | Patrice Nedelec AMICAS, INC. 20 GUEST ST. Brighton, 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 | 2002-09-06 |
| Decision Date | 2002-11-22 |
| Summary: | summary |