The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Hitachi Presto.
| Device ID | K040902 |
| 510k Number | K040902 |
| Device Name: | HITACHI PRESTO |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087 |
| Contact | Douglas Thistlethwaite |
| Correspondent | Derwyn Reuber INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-04-07 |
| Decision Date | 2004-04-21 |
| Summary: | summary |