3VISEON
System, Image Processing, Radiological
3MENSIO MEDICAL IMAGING BV
The following data is part of a premarket notification filed by 3mensio Medical Imaging Bv with the FDA for 3viseon.
Pre-market Notification Details
| Device ID | K043097 |
| 510k Number | K043097 |
| Device Name: | 3VISEON |
| Classification | System, Image Processing, Radiological |
| Applicant | 3MENSIO MEDICAL IMAGING BV 1600 MANCHESTER WAY Corinth, TX 76210 |
| Contact | Carl Alletto |
| Correspondent | N.e. Devine, Jr. ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-11-09 |
| Decision Date | 2004-11-19 |
| Summary: | summary |
Trademark Results [3VISEON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 3VISEON 79019904 3209383 Dead/Cancelled |
3mensio Medical Imaging BV 2005-05-04 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.