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 | K160432 |
| 510k Number | K160432 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-16 |
| Decision Date | 2016-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14987718300246 | K160432 | 000 |