The following data is part of a premarket notification filed by Scimage, Inc. with the FDA for Netra Workstation System & Netra Md Software.
| Device ID | K960911 |
| 510k Number | K960911 |
| Device Name: | NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE |
| Classification | System, Digital Image Communications, Radiological |
| Applicant | SCIMAGE, INC. 25500 CRESCENT LN. Los Altos, CA 94022 -4521 |
| Contact | Sai P Raya |
| Correspondent | Sai P Raya SCIMAGE, INC. 25500 CRESCENT LN. Los Altos, CA 94022 -4521 |
| Product Code | LMD |
| CFR Regulation Number | 892.2020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-06 |
| Decision Date | 1996-05-29 |
| Summary: | summary |