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Shimadzu RADspeed fit Radiography System - HSA Registration DE0501688

Access comprehensive regulatory information for Shimadzu RADspeed fit Radiography System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0501688 and owned by Shimadzu Corporation. The device was registered on June 01, 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.

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CLASS C
DE0501688
Shimadzu RADspeed fit Radiography System
HSA Registration Number: DE0501688
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Product Description

Radiography System RADspeed fit is an X-ray radiographic system suitable for radiography for each region of a patient in horizontal or vertical position. This system can be used for the following radiography: -Digital radiography using a flat panel detector -General radiography using an X-ray film cassette or CR cassette

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0501688
Registration Date
June 01, 2018
Retention Due Date
May 31, 2025
Product Owner
Short Name
Shimadzu Corporation
Address
1 Nishinokyo-Kuwabaracho, Nakagyo-ku, Kyoto 604-8511, JAPAN
Registrant
Address
79 SCIENCE PARK DRIVE, CINTECH IV, #02-01/08, SINGAPORE 118264
Importer
Address
79 SCIENCE PARK DRIVE, CINTECH IV, #02-01, SINGAPORE 118264
Model Information
Model Name(s)
X-ray tube assembly X-ray tube assembly X-ray tube assembly BR-120fit Cassette Holder Radiography System RADSpeed fit Radiography System RADSpeed fit Grid S1040-100M Grid S1240-170M Handswitch Overhead hand grip Phototimer SPT-XD-A1A Phototimer SPT-XD-A3B Phototimer SPT-XD-A4A Side Hand Grip
Model Identifier(s)
0.6/1.2P13DK-85 0.6/1.2P164DK-85 0.6/1.2P18DE-85 BR-120fit Cassette Holder D150L-FT32 D150L-FT56 Grid S1040-100M Grid S1240-170M Handswitch Overhead hand grip SPT-XD-A1A SPT-XD-A3B SPT-XD-A4A Side hand grip