The following data is part of a premarket notification filed by Ohio Imaging, Inc. with the FDA for Model 3000 Nuclear Camera.
| Device ID | K882312 |
| 510k Number | K882312 |
| Device Name: | MODEL 3000 NUCLEAR CAMERA |
| Classification | Camera, Scintillation (gamma) |
| Applicant | OHIO IMAGING, INC. 23060 MILES RD. Bedford Heights, OH 44128 |
| Contact | Edward A Kroll |
| Correspondent | Edward A Kroll OHIO IMAGING, INC. 23060 MILES RD. Bedford Heights, OH 44128 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-03 |
| Decision Date | 1988-07-14 |