The following data is part of a premarket notification filed by Reality Imaging Corp. with the FDA for Voxel Flinger(tm) 3-d Imaging System.
| Device ID | K883476 |
| 510k Number | K883476 |
| Device Name: | VOXEL FLINGER(TM) 3-D IMAGING SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | REALITY IMAGING CORP. 6661 COCHRAN RD. SOLON, OH 44139 |
| Contact | DENNIS J HEGLER |
| Correspondent | DENNIS J HEGLER REALITY IMAGING CORP. 6661 COCHRAN RD. SOLON, OH 44139 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-16 |
| Decision Date | 1988-11-23 |