The following data is part of a premarket notification filed by 3mensio Medical Imaging Bv with the FDA for 3viseon/surgery.
| Device ID | K072653 |
| 510k Number | K072653 |
| Device Name: | 3VISEON/SURGERY |
| Classification | System, Image Processing, Radiological |
| Applicant | 3MENSIO MEDICAL IMAGING BV 1600 MANCHESTER WAY Denton, TX 76210 |
| Contact | Carl Thomas |
| Correspondent | Carl Thomas 3MENSIO MEDICAL IMAGING BV 1600 MANCHESTER WAY Denton, TX 76210 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-20 |
| Decision Date | 2008-01-24 |
| Summary: | summary |