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Ray Rayscan α Dental X-ray Systems - HSA Registration DE0503544

Access comprehensive regulatory information for Ray Rayscan α Dental X-ray Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503544 and owned by Ray Co., Ltd. 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
DE0503544
Ray Rayscan α Dental X-ray Systems
HSA Registration Number: DE0503544
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Product Description

Intended for panoramic X-ray imaging system with Cephalostat is an extra-oral source X-ray system, intended for dental radiographic examination of the teeth, jaw and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry, 2D images are obtained using the standard narrow beam technique. The RAYSCAN α–3D, SM3D, M3DL, M3DS, RCT 700 is also capable, using the CBVT technique, of generating dental maxillofacial 3D images. The device employs a cone-shaped X-ray beam projected onto a flat panel detector, and the examined volume image is reconstructed as a 3D image.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0503544
Registration Date
September 03, 2019
Retention Due Date
September 02, 2025
Product Owner
Short Name
Ray Co., Ltd
Address
332-7. Samsung 1-ro, Hwaseong-si,, Gyeonggi-do, 18380, KOREA, REPUBLIC OF
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)
Rayscan a-3D Rayscan a-M3DL Rayscan a-M3DS Rayscan a-OCL Rayscan a-OCS Rayscan a-P Rayscan a-SC Rayscan a-SM3D
Model Identifier(s)
Rayscan a-3D Rayscan a-M3DL Rayscan a-M3DS Rayscan a-OCL Rayscan a-OCS Rayscan a-P Rayscan a-SC Rayscan a-SM3D