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Singapore HSA registration DE0501932

Shimadzu Digital Radiography System RADspeed Pro

Singapore flagSingapore·CLASS C·Shimadzu Corporation·Registered July 23, 2018
Device classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0501932
Registration Date
July 23, 2018
Change Notification Approval Date
April 11, 2023
Retention Due Date
July 22, 2025
Product description
The RADspeed Pro is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The RADspeed Pro enables radiographic or tomographic exposures of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The device is not intended for mammographic applications
Product Owner
Name
Shimadzu Corporation
Short Name
Shimadzu Corporation
Address
1 Nishinokyo-Kuwabaracho, Nakagyo-ku, Kyoto 604-8511, JAPAN
Registrant
Name
SHIMADZU (ASIA PACIFIC) PTE LTD
Address
79 SCIENCE PARK DRIVE, CINTECH IV, #02-01/08, SINGAPORE 118264
Importer
Name
SHIMADZU (ASIA PACIFIC) PTE LTD
Address
79 SCIENCE PARK DRIVE, CINTECH IV, #02-01, SINGAPORE 118264
Model information
Model Name(s)
X-ray Tube X-ray Tube X-ray Tube X-ray Tube X-ray Tube X-ray Tube X-ray Tube X-ray Tube X-ray Tube X-ray Tube X-ray Tube X-ray Radiography Table X-ray Radiography Table X-ray Radiography Table X-ray Radiography Stand X-ray Radiography Stand X-ray Radiography Stand X-ray Tube Support X-ray Tube Support Control Cabinet Control Cabinet Control Cabinet Control Cabinet X-ray Tube Support X-ray Collimator X-ray Collimator Digital Radiography System RADspeed Pro
Model Identifier(s)
0.6/1.2P13DK-85 0.6/1.2P164DK-85 0.6/1.2P18DE-85 0.6/1.2P324DK-85 0.6/1.2P33DK-85 0.6/1.2P364DK-85 0.6/1.2P38DE-85 1/2P13DK-85 1/2P18DK-85 1/2P33D-85 1/2P38D-85 BK-120MK BK-12HK BK-200 BR-120 BR-120M BR-120T CH-200 CH-200M D150BC-40 D150BC-41 D150LC-41 D150VC-41 FH-21HR R-20J R-300 RADspeed Pro
About this record

Access comprehensive regulatory information for Shimadzu Digital Radiography System RADspeed Pro in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0501932 and owned by Shimadzu Corporation. The device was registered on July 23, 2018.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C