The following data is part of a premarket notification filed by Hitachi,ltd. , Health Care Company with the FDA for Extended Range Shifter For Probeat-v.
| Device ID | K152207 |
| 510k Number | K152207 |
| Device Name: | Extended Range Shifter For PROBEAT-V |
| 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 | 2015-08-06 |
| Decision Date | 2015-10-02 |
| Summary: | summary |