Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8031557

FEI Number

3008328959

Entity Name

ANZAI MEDICAL CO, LTD.

City/State/Country

SHINAGAWA-KU Tokyo, JP

Establishment Address

2-6-9 OHSAKI, SHINAGAWA-KU Tokyo 141-0023, JP

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

ANZAI MEDICAL CO, LTD. (Owner Number: 8031557)

Owner / Operator Contact Address

3-9-15 NISHI-SHINAGAWA, SHINAGAWA-KU, TOKYO, JP-NOTA 141-0033, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K170719

PMA Number

N/A

All Registered Proprietary Names

AZ-733VI Respiratory Gating System AZ-733V & AZ-733VI AZ-M1PP Motion Phantom Platform AZ-M2PP Motion Phantom Platform AZ-733V & AZ-733VI AZ-733VI Respiratory Gating System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LHN	System, Radiation Therapy, Charged-Particle, Medical	Radiology	Class 2	892.5050	2016-05-13
IXO	Synchronizer, Ecg / Respirator, Radiographic	Radiology	Class 1	892.1970	2004-01-27
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	2026-06-02
LHN	System, Radiation Therapy, Charged-Particle, Medical	Radiology	Class 2	892.5050	2008-10-20
LHN	System, Radiation Therapy, Charged-Particle, Medical	Radiology	Class 2	892.5050	2017-04-10

Official Correspondent

Masako Kobayashi

US Agent Details

Carole C Carey Business: C3-Carey Consultants, LLC Email: carolecarey@mac.com Phone: (301) 3952249

Related Public Records

Same Entity

ANZAI MEDICAL CO, LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2009	Intraop Medical Corporation	2	Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site.

Similar Registrations

Registration Number	Establishment Name	Location
3016872563	EHMET HEALTH	Plymouth, MI, US
3015232217	ELEKTA SOLUTIONS AB	STOCKHOLM, SE
8043933	BRAINLAB SE	Munich Bavaria, DE
3010658895	Varian Medical Systems Particle Therapy GmbH & Co. KG	Troisdorf North Rhine-Westphalia, DE
3015178562	McLaren Health Care	Flint, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8031557. Last updated year: 2026. Please use registration number 8031557 when referencing this establishment in official correspondence.