Data / Medical devices / Japan / Anzai Medical Co, Ltd.
Anzai Medical Co, Ltd.: FDA-registered device maker in SHINAGAWA-KU Tokyo, Japan, 3 510(k) clearances
Anzai Medical Co, Ltd. is registered with the FDA (registration 8031557) in SHINAGAWA-KU Tokyo, Japan. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 5, 2017. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8031557
- FEI number
- 3008328959
- Address
- 2-6-9 Ohsaki, SHINAGAWA-KU Tokyo, Japan, 141-0023
- Owner or operator
- ANZAI MEDICAL CO, LTD. (8031557)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 27, 2004
- Registered through
- 2027
- Brand names listed
- AZ-733V & AZ-733VI, AZ-733VI Respiratory Gating System, AZ-M1PP Motion Phantom Platform, AZ-M2PP Motion Phantom Platform
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Quality-Assurance, Radiologic | LHO | 1 | Manufacturer | accessdata.fda.gov |
| Synchronizer, Ecg / Respirator, Radiographic | IXO | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Radiation Therapy, Charged-Particle, Medical | LHN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 5, 2017 | K170719 | Anzai Respiratory Gating System | LHN | Substantially Equivalent | Anzai Medical Co., Ltd. | accessdata.fda.gov |
| April 22, 2016 | K160432 | Anzai Respiratory Gating System | LHN | Substantially Equivalent | Anzai Medical Co., Ltd. | accessdata.fda.gov |
| November 10, 2003 | K031385 | ANZAI AZ-733 RESPIRATORY GATING SYSTEM | LHN | Substantially Equivalent | Anzai Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Radiation Therapy, Charged-Particle, Medical
- All makers of Synchronizer, Ecg / Respirator, Radiographic
- All makers of Instrument, Quality-Assurance, Radiologic
Updated April 5, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.