The following data is part of a premarket notification filed by General Medical Equipment Corp. with the FDA for Pixell Mri System.
| Device ID | K962249 |
| 510k Number | K962249 |
| Device Name: | PIXELL MRI SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GENERAL MEDICAL EQUIPMENT CORP. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Contact | Richard C Lanzillotto |
| Correspondent | Richard C Lanzillotto GENERAL MEDICAL EQUIPMENT CORP. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-11 |
| Decision Date | 1997-01-10 |