The following data is part of a premarket notification filed by Anzai Medical Co, Ltd. with the FDA for Anzai Az-733 Respiratory Gating System.
| Device ID | K031385 |
| 510k Number | K031385 |
| Device Name: | ANZAI AZ-733 RESPIRATORY GATING SYSTEM |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | ANZAI MEDICAL CO, LTD. 2305 GOLD MINE RD. Brookeville, MD 20833 -2233 |
| Contact | T. Whit Athey |
| Correspondent | T. Whit Athey ANZAI MEDICAL CO, LTD. 2305 GOLD MINE RD. Brookeville, MD 20833 -2233 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-01 |
| Decision Date | 2003-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14987718300093 | K031385 | 000 |