The following data is part of a premarket notification filed by The Medipattern Corporation with the FDA for Visualize: Vascular.
| Device ID | K103761 |
| 510k Number | K103761 |
| Device Name: | VISUALIZE: VASCULAR |
| Classification | System, Image Processing, Radiological |
| Applicant | THE MEDIPATTERN CORPORATION 3080 YOUNGE STREET SUITE 4070 Toronto, On, CA M4n 3n1 |
| Contact | Erin Walsh |
| Correspondent | Erin Walsh THE MEDIPATTERN CORPORATION 3080 YOUNGE STREET SUITE 4070 Toronto, On, CA M4n 3n1 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-23 |
| Decision Date | 2011-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B725INITVV1 | K103761 | 000 |