FDA.reportPublic FDA data

NA

Primary DI
14987718300253
Brand
NA
Company
ANZAI MEDICAL CO., LTD.
Model
AZ-733VI
Published
2017-04-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHNSystem, Radiation Therapy, Charged-Particle, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHNSystem, Radiation Therapy, Charged-Particle, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170719000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170719000Anzai Respiratory Gating SystemAnzai Medical Co., Ltd.2017-04-05LHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14987718300253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1498771830025314987718300253

GMDN Terms#

Term, Definition table
TermDefinition
Accelerator system synchronizerA physiological monitoring unit used as a component of an accelerator system that produces a signal which enables the acceleration path of excited particles, usually electrons, and image formation or data collection to be synchronized with a specific measurable physiological parameter, e.g., the beginning of a patient's respiratory or cardiac cycle. It is primarily used as a trigger for accelerator system application and artifact reduction, or enhancement of signal-to-noise ratios in various real-time applications.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+81337791611info@anzai-med.co.jp

Regulatory Flags#

DUNS number
701259533
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14987718300093NAAZ-733V2016-09-10
14987718300246NAAZ-733VI2016-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850065937007eMotusEMPNIA INC.LHN2026-09-21
00850065937014eMotusEMPNIA INC.LHN2026-09-21
00850065937021eMotusEMPNIA INC.LHN2026-09-21
00850065937038eMotusEMPNIA INC.LHN2026-09-21
00850065937045eMotusEMPNIA INC.LHN2026-09-21
00850065937052eMotusEMPNIA INC.LHN2026-09-21
00850065937069eMotusEMPNIA INC.LHN2026-09-21
00850065937076eMotusEMPNIA INC.LHN2026-09-21
00850065937083eMotusEMPNIA INC.LHN2026-09-21
00850065937090eMotusEMPNIA INC.LHN2026-09-21
00850065937106eMotusEMPNIA INC.LHN2026-09-21
00850065937113eMotusEMPNIA INC.LHN2026-09-21
00850065937120eMotusEMPNIA INC.LHN2026-09-21
00850065937137eMotusEMPNIA INC.LHN2026-09-21
00850065937144eMotusEMPNIA INC.LHN2026-09-21
00850065937151eMotusEMPNIA INC.LHN2026-09-21
00850065937168eMotusEMPNIA INC.LHN2026-09-21
00850065937175eMotusEMPNIA INC.LHN2026-09-21
00850065937182eMotusEMPNIA INC.LHN2026-09-21
00850065937199eMotusEMPNIA INC.LHN2026-09-21
00850065937205eMotusEMPNIA INC.LHN2026-09-21
00850065937212eMotusEMPNIA INC.LHN2026-09-21
00850065937229eMotusEMPNIA INC.LHN2026-09-21
00850065937236eMotusEMPNIA INC.LHN2026-09-21
00850065937243eMotusEMPNIA INC.LHN2026-09-21
00850065937250eMotusEMPNIA INC.LHN2026-09-21
00850065937267eMotusEMPNIA INC.LHN2026-09-21
00850065937274eMotusEMPNIA INC.LHN2026-09-21
00850065937298eMotusEMPNIA INC.LHN2026-09-21
00850065937304eMotusEMPNIA INC.LHN2026-09-21