The following data is part of a premarket notification filed by Hitachi, Ltd., Health Care Company with the FDA for Probeat-v And Accessories.
| Device ID | K153614 |
| 510k Number | K153614 |
| Device Name: | PROBEAT-V And Accessories |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | HITACHI, LTD., HEALTH CARE COMPANY 4-14-1 SOTOKANDA, CHIYODA-KU Tokyo, JP 101-8010 |
| 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 | 2015-12-17 |
| Decision Date | 2016-04-21 |
| Summary: | summary |