The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Hitachi Supria Whole-body X-ray Ct System Phase 3.
| Device ID | K163528 |
| 510k Number | K163528 |
| Device Name: | HITACHI Supria Whole-body X-ray CT System Phase 3 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park Twinsburg, OH 44087 |
| Contact | Doug Thistlethwaite |
| Correspondent | Doug Thistlethwaite Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park Twinsburg, OH 44087 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-16 |
| Decision Date | 2017-03-03 |
| Summary: | summary |