The following data is part of a premarket notification filed by 3m Imtec with the FDA for Iluma Vision Model Version 2.2.
| Device ID | K094064 |
| 510k Number | K094064 |
| Device Name: | ILUMA VISION MODEL VERSION 2.2 |
| Classification | System, Image Processing, Radiological |
| Applicant | 3M IMTEC 3M CENTER BLDG 275-2W-08 St Paul, MN 55144 -1000 |
| Contact | Ginger Cantor, Rac |
| Correspondent | Ginger Cantor, Rac 3M IMTEC 3M CENTER BLDG 275-2W-08 St Paul, MN 55144 -1000 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-31 |
| Decision Date | 2010-04-30 |
| Summary: | summary |