The following data is part of a premarket notification filed by Ugm Medical Systems, Inc. with the FDA for Penn-pet Scanner.
| Device ID | K945721 |
| 510k Number | K945721 |
| Device Name: | PENN-PET SCANNER |
| Classification | System, Tomography, Computed, Emission |
| Applicant | UGM MEDICAL SYSTEMS, INC. 3401 MARKET ST. SUITE 222 Philadelphia, PA 19104 |
| Contact | Gerd Muehllehner |
| Correspondent | Gerd Muehllehner UGM MEDICAL SYSTEMS, INC. 3401 MARKET ST. SUITE 222 Philadelphia, PA 19104 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-21 |
| Decision Date | 1995-04-07 |