Pure Global
210234
III
current

Radiographic Systems, Digital, Mammographicๆ”พๅฐ„ๆˆๅƒ็ณป็ปŸ,ๆ•ฐๅญ—,ไนณ่…บ X ็บฟๆ‘„ๅฝฑ

This profile provides complete Hong Kong MDACS registration information for Radiographic Systems, Digital, Mammographic. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.

Product Info: Radiographic Systems, Digital, Mammographic

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
18432
Product Code Detail
18432 Radiographic Systems, Digital, Mammographic
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
United States
็พŽๅ›ฝ
36, Apple Ridge Road, Danbury, CT 06810, USA
36, ่‹นๆžœๅฒญ่ทฏ, ไธนไผฏ้‡Œ, CT 06810, ็พŽๅ›ฝ
Authorised Representative (AR)
Prism Technologies Limited
ๆฃฑ็ง‘ๆœ‰้™ๅ…ฌๅธ
27863233
Regulatory Timeline
Registration Date
January 19, 2023
Expiry Date
July 22, 2026
Product Models
Selenia Dimensions 2D System, 6000 (SDM-SYS-6000-2D), Selenia Dimensions 3D System, 6000 (SDM-SYS-6000-3D), 3Dimensions System 2D, International (3DM-SYS-INTL2D), 3Dimensions System 3D, International (3DM-SYS-INTL-3D), Dimensions License, Clarity HD (ASY-10832(SDM), DIM-LIC-CHD(3DM)), Dimensions License, Intelligent 2D (DIM-LIC-I2D), Contrast Enhanced Digital Mammography (I-View) (ASY-08109, ASY-14055(2.0)), C-View (SDM-LIC-0005), SmartCurve (DIM-ASY-SCS, DIM-ASY-SCS-2)
Selenia Dimensions 2D System, 6000 (SDM-SYS-6000-2D), Selenia Dimensions 3D System, 6000 (SDM-SYS-6000-3D), 3Dimensions System 2D, International (3DM-SYS-INTL2D), 3Dimensions System 3D, International (3DM-SYS-INTL-3D), Dimensions License, Clarity HD (ASY-10832(SDM), DIM-LIC-CHD(3DM)), Dimensions License, Intelligent 2D (DIM-LIC-I2D), CONTRAST Enhanced Digital MaX ๅ…‰ๆฃ€ๆŸฅ (I-View) (ASY-08109, ASY-14055(2.0)), C-View (SDM-LIC-0005), SmartCurve (DIM-ASY-SCS, DIM-ASY-SCS-2)