The following data is part of a premarket notification filed by Imaging Sciences International (dba Gendex Llc) with the FDA for Vixwin Platinum.
| Device ID | K141451 |
| 510k Number | K141451 |
| Device Name: | VixWin Platinum |
| Classification | System, Image Processing, Radiological |
| Applicant | IMAGING SCIENCES INTERNATIONAL (DBA GENDEX LLC) 1910 NORTH PENN ROAD Hatfield, PA 19440 |
| Contact | Sanjay Ahuja |
| Correspondent | Sanjay Ahuja IMAGING SCIENCES INTERNATIONAL (DBA GENDEX LLC) 1910 NORTH PENN ROAD Hatfield, PA 19440 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-02 |
| Decision Date | 2014-08-26 |
| Summary: | summary |