Radiographic Systems, Digital, Mammographic

放射成像系统,数字,乳腺 X 线摄影

Hologic, Inc.·III·Hong Kong MDACS·Registered January 19, 2023

Device overview

Risk class: III
Product code: 18432
State: current
Status: N/A
Product code detail: 18432 Radiographic Systems, Digital, Mammographic

Manufacturer (製造商)

Name: Hologic, Inc.
Hologic
Country: United States
美国
Address: 36, Apple Ridge Road, Danbury, CT 06810, USA
36, 苹果岭路, 丹伯里, CT 06810, 美国

Authorised representative (AR)

Name: Prism Technologies Limited
棱科有限公司
Phone: 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 光检查 (I-View) (ASY-08109, ASY-14055(2.0)), C-View (SDM-LIC-0005), SmartCurve (DIM-ASY-SCS, DIM-ASY-SCS-2)

About this record

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

產品資訊： 放射成像系统,数字,乳腺 X 线摄影