The following data is part of a premarket notification filed by Biotex, Inc. with the FDA for Visualase Envision Software System.
| Device ID | K063505 |
| 510k Number | K063505 |
| Device Name: | VISUALASE ENVISION SOFTWARE SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | BIOTEX, INC. 8058 EL RIO ST. Houston, TX 77054 -4185 |
| Contact | Mathew Fox |
| Correspondent | Mathew Fox BIOTEX, INC. 8058 EL RIO ST. Houston, TX 77054 -4185 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-20 |
| Decision Date | 2006-12-12 |
| Summary: | summary |