The following data is part of a premarket notification filed by Positron Corp. with the FDA for Mpower, Model 712 Series.
| Device ID | K022001 |
| 510k Number | K022001 |
| Device Name: | MPOWER, MODEL 712 SERIES |
| Classification | System, Tomography, Computed, Emission |
| Applicant | POSITRON CORP. 1304 LANGHAM CREEK DR., #300 Houston, TX 77084 |
| Contact | Irene C Albright |
| Correspondent | Irene C Albright POSITRON CORP. 1304 LANGHAM CREEK DR., #300 Houston, TX 77084 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-19 |
| Decision Date | 2002-07-12 |