The following data is part of a premarket notification filed by Hitachi, Ltd. with the FDA for Probeat-v Proton Beam Therapy System With X-ray Limiting Accessory.
| Device ID | K161163 |
| 510k Number | K161163 |
| Device Name: | PROBEAT-V Proton Beam Therapy System With X-ray Limiting Accessory |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | HITACHI, LTD. 2-16-1 HIGACHI-UENO TAITO-KU Tokyo, JP 10-0015 |
| Contact | Naoya Nishimura |
| Correspondent | Jonathan Kahan HOGAN LOVELLS US LLP 555 13TH STREET NW Washington, DC 20016 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-25 |
| Decision Date | 2016-07-13 |
| Summary: | summary |