The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Magnetic Resonance Imaging Uniformity/t1 76-901.
| Device ID | K853754 |
| 510k Number | K853754 |
| Device Name: | MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901 |
| Classification | Instrument, Quality-assurance, Radiologic |
| Applicant | VICTOREEN, INC. 100 VOICE RD. Carle Place, NY 11514 |
| Contact | Glasser |
| Correspondent | Glasser VICTOREEN, INC. 100 VOICE RD. Carle Place, NY 11514 |
| Product Code | LHO |
| CFR Regulation Number | 892.1940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-09 |
| Decision Date | 1986-05-07 |