The following data is part of a premarket notification filed by Anzai Medical Co., Ltd. with the FDA for Anzai Respiratory Gating System.
| Device ID | K170719 |
| 510k Number | K170719 |
| Device Name: | Anzai Respiratory Gating System |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | Anzai Medical Co., Ltd. 3-9-15 Nishi-Shinagawa Shinagawa-ku Tokyo, JP 141-0033 |
| Contact | Naoya Iwasaki |
| Correspondent | Carole C. Carey C3-Carey Consultants, LLC 9451 Ellsworth Court Fulton, MD 20759 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-09 |
| Decision Date | 2017-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14987718300253 | K170719 | 000 |