The following data is part of a premarket notification filed by Hitachi, Ltd. Healthcare with the FDA for Real Time Image Gating System For Proton Beam Therapy Systems.
| Device ID | K171049 |
| 510k Number | K171049 |
| Device Name: | Real Time Image Gating System For Proton Beam Therapy Systems |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | Hitachi, Ltd. Healthcare 2-16-1 Higachi-Ueno, Taito-ku Tokyo, JP |
| Contact | Tomoyuki Seino |
| 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 | 2017-04-07 |
| Decision Date | 2017-12-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560333350228 | K171049 | 000 |