Singapore HSA registration DE0015843
Shimadzu Mobile X-ray system FDR Go (PLUS Version)
Singapore·CLASS C·Shimadzu Corporation·Registered July 07, 2014Device 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 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.
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
About this record
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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