The following data is part of a premarket notification filed by Ohio Imaging, Inc. with the FDA for Prism 1500xp Nuclear Gamma Camera System.
| Device ID | K945261 |
| 510k Number | K945261 |
| Device Name: | PRISM 1500XP NUCLEAR GAMMA CAMERA SYSTEM |
| Classification | System, Tomography, Computed, Emission |
| Applicant | OHIO IMAGING, INC. 23060 MILES RD. Bedford Heights, OH 44128 |
| Contact | Norman J Yager |
| Correspondent | Norman J Yager OHIO IMAGING, INC. 23060 MILES RD. Bedford Heights, OH 44128 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-28 |
| Decision Date | 1995-03-21 |