The following data is part of a premarket notification filed by Hitachi, Ltd., Power Systems Group with the FDA for Probeat With Discrete Spot Scanning System.
| Device ID | K073059 |
| 510k Number | K073059 |
| Device Name: | PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | HITACHI, LTD., POWER SYSTEMS GROUP 555 THIRTEENTH STREET, NW COLUMBIA SQUARE Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan HITACHI, LTD., POWER SYSTEMS GROUP 555 THIRTEENTH STREET, NW COLUMBIA SQUARE 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 | 2007-10-30 |
| Decision Date | 2007-12-10 |
| Summary: | summary |