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Shimadzu Mobile X-ray system FDR Go (PLUS Version) - HSA Registration DE0015843

Access comprehensive regulatory information for Shimadzu Mobile X-ray system FDR Go (PLUS Version) in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0015843 and owned by Shimadzu Corporation. The device was registered on July 07, 2014.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0015843
Shimadzu Mobile X-ray system FDR Go (PLUS Version)
HSA Registration Number: DE0015843
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Product Description

The FDR Go (PLUS Version) is a mobile X-ray system. The system can be moved freely throughout a hospital to directly obtain X-ray images of various area of the body.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0015843
Registration Date
July 07, 2014
Change Notification Approval Date
January 24, 2025
Retention Due Date
July 06, 2025
Product Owner
Short Name
Shimadzu Corporation
Address
1, Nishinokyo-Kuwabaracho,, Nakagyo-ku, Kyoto 604-8511, Japan, JAPAN
Registrant
Address
10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Importer
Address
10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Model Information
Model Name(s)
CR CONSOLE ,IR DICOM PRINT E CR CONSOLE ,IR DICOM COMMITMENT E CR CONSOLE ,IR DICOM MPPS E CR CONSOLE ,IR DICOM ID MWM E CR CONSOLE ,IR DICOM ORDER MWM E CR CONSOLE ,IR DICOM DICOM QR E CR CONSOLE ,IR DICOM RETAKE ANALYSIS E CR CONSOLE ,IR DICOM DICOM PDI STORAGE E CR CONSOLE ,IR DICOM DICOM MEDIA STORAGE E CR CONSOLE ,IR DICOM QC TEST SOFT E FDR Go (Plus version) Flat panel sensor detector Flat panel sensor detector Flat panel sensor detector Flat panel sensor detector Console Advance Interafce unit Panel Unit Control software
Model Identifier(s)
15943831 15943843 15943855 15943867 15943879 15943893 15943908 15943922 15997038 16174047 566-20000-18 DR-ID 601SE DR-ID 602SE DR-ID 611SE DR-ID 613SE DR-ID 800CL DR-ID800IU DR-ID800MC