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Turner Smart-C X-Ray Imaging System - HSA Registration DE0510434

Access comprehensive regulatory information for Turner Smart-C X-Ray Imaging 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 DE0510434 and owned by Turner Imaging Systems,Inc. The device was registered on March 07, 2025.

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
DE0510434
Turner Smart-C X-Ray Imaging System
HSA Registration Number: DE0510434
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Product Description

The Smart-C is a mini c-arm x-ray system designed to provide physicians with real time general fluoroscopic visualization of adult and pediatric patients. It is intended to aid physicians and surgeons during diagnostic procedures, therapeutic treatment, or surgical procedures of the limbs, extremities, or shoulders including but not limited to, orthopedics and emergency medicine. The Smart-C is intended to be used on a table or other hard flat surface. It may also be used with the optional support stand.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0510434
Registration Date
March 07, 2025
Retention Due Date
March 06, 2026
Product Owner
Short Name
Turner Imaging Systems,Inc
Address
1119 S 1680 W, Orem Utah 84058, UNITED STATES
Registrant
Address
196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384
Importer
Address
196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384 196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384
Model Information
Model Name(s)
Footswitch Tablet Smart-C System Support Stand for Smart-C Monitor Cart for Smart-C
Model Identifier(s)
838-00003-001 838-00018 962-00001-GB 962-00003-002-GB 962-00004-002-GB