The following data is part of a premarket notification filed by Hitachi, Ltd. with the FDA for Probeat With Mgcs.
| Device ID | K060834 |
| 510k Number | K060834 |
| Device Name: | PROBEAT WITH MGCS |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | HITACHI, LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Jonathan S Kahn |
| Correspondent | Jonathan S Kahn HITACHI, LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-27 |
| Decision Date | 2006-04-19 |
| Summary: | summary |