The following data is part of a premarket notification filed by Millensys with the FDA for Vision Tools.
| Device ID | K090668 |
| 510k Number | K090668 |
| Device Name: | VISION TOOLS |
| Classification | System, Image Processing, Radiological |
| Applicant | MILLENSYS 24 SLABTOWN CREEK RD. Blairstown, NJ 07825 |
| Contact | Christine Nichols |
| Correspondent | Christine Nichols MILLENSYS 24 SLABTOWN CREEK RD. Blairstown, NJ 07825 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-13 |
| Decision Date | 2009-06-23 |