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Control-X Medical Z-motion X-ray System - HSA Registration DE0503548

Access comprehensive regulatory information for Control-X Medical Z-motion X-ray 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 DE0503548 and owned by Control X Medical. The device was registered on September 03, 2019.

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
DE0503548
Control-X Medical Z-motion X-ray System
HSA Registration Number: DE0503548
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Product Description

The Z-Motion System is intended for holding and positioning the x-ray tube and the x-ray imager. Its applications include (but are not limited to): Chest and chiropractic radiography, general gastrointestinal radiograms, extremities work, lateral exposures with the patient standing, emergency radiography when equipped with gurney / trolley table. It cannot be use for fluoroscopy / fluorography procedures.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0503548
Registration Date
September 03, 2019
Retention Due Date
September 02, 2025
Product Owner
Short Name
Control X Medical
Address
1755 Atlas Street, OH 43228, UNITED STATES
Registrant
Address
75 BUKIT TIMAH ROAD, BOON SIEW BUILDING, #06-13, SINGAPORE 229833
Importer
Address
75 BUKIT TIMAH ROAD, BOON SIEW BUILDING, #06-13, SINGAPORE 229833
Model Information
Model Name(s)
Apex HF Series (Analogue) Apex HF Series (Analogue) Apex HF Series (Analogue) Apex HF Series (Analogue) Apex HF Series (Analogue) Toshiba X-ray Tube Series Toshiba X-ray Tube Series Toshiba X-ray Tube Series Toshiba X-ray Tube Series Toshiba X-ray Tube Series Toshiba X-ray Tube Series Toshiba X-ray Tube Series Milestone Series Milestone Series Milestone Series Milestone Series Milestone Series PCX Series PCX Series PCX Series PCX Series PCX Series Varian X-ray Tube Series Varian X-ray Tube Series Varian X-ray Tube Series Varian X-ray Tube Series Varian X-ray Tube Series Varian X-ray Tube Series Varian X-ray Tube Series Varian X-ray Tube Series Milestone Series Milestone Series Milestone Series Milestone Series Z-motion X-ray System
Model Identifier(s)
Apex APX 325/350 HF Apex APX 425/450 HF Apex APX 550 HF Apex APX 850 HF Apex PCX 1050 HF E7239X E7240X E7242X E7252X E7864X E7869X E7884X MS 1050 HF STR 100 MS 850 HF STR 100 MS HF LC 325/350 MS HF LC 425/450 MS HF LC 525/550 PCX HF 1050 PCX HF 325/350 PCX HF 425/450 PCX HF 525/550 PCX HF 850 RAD 13 RAD 14 RAD 21 RAD 56 RAD 60 RAD 74 RAD 8 RAD 92 SE MS 450-10 SE MS 450-6 SE MS 550-20 SE MS 550-30 Z-Motion