The following data is part of a premarket notification filed by Reality Imaging Corp. with the FDA for Coxel Flinger 2500/5000 3-d Imaging System.
| Device ID | K912410 |
| 510k Number | K912410 |
| Device Name: | COXEL FLINGER 2500/5000 3-D IMAGING SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | REALITY IMAGING CORP. 6661 COCHRAN RD. SOLON, OH 44139 |
| Contact | CARL J HOWE |
| Correspondent | CARL J HOWE REALITY IMAGING CORP. 6661 COCHRAN RD. SOLON, OH 44139 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-31 |
| Decision Date | 1991-08-13 |