The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Sceptrep3 Pet/ct.
| Device ID | K042428 |
| 510k Number | K042428 |
| Device Name: | SCEPTREP3 PET/CT |
| Classification | System, Tomography, Computed, Emission |
| Applicant | HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087 |
| Contact | Douglass Thistlethwaite |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-09-08 |
| Decision Date | 2004-09-17 |
| Summary: | summary |