The following data is part of a premarket notification filed by Scimage, Inc. with the FDA for Netra Workstation And Netramd Software.
| Device ID | K003484 |
| 510k Number | K003484 |
| Device Name: | NETRA WORKSTATION AND NETRAMD SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | SCIMAGE, INC. 4916 EL CAMINO REAL, SUITE 200 Los Altos, CA 94022 |
| Contact | Michael Peter |
| Correspondent | Michael Peter SCIMAGE, INC. 4916 EL CAMINO REAL, SUITE 200 Los Altos, CA 94022 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-09 |
| Decision Date | 2001-01-19 |