Medical Device Division · registration 210234CancelledHologic
Hong KongRadiographic Systems, Digital, MammographicClass IIIHologic, Inc.
Official record identity
- MDACS listing number
- 210234
- Model name
- 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)
- Registration date
- January 19, 2023
- Source update date
- September 17, 2025
- Status
- Cancelled
Official value: Delisted
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Prism Technologies Limited
- Manufacturer
- Hologic, Inc.
Official description
Radiographic Systems, Digital, Mammographic
Additional source fields
- AMD nomenclature code
- 18432
- Traditional Chinese local responsible person
- 稜科有限公司
- Local responsible person phone
- 27863233
- Published manufacturer address
- 36, Apple Ridge Road, Danbury, CT 06810, USA
- Published remarks
- Delisted.
- Revision number
- a
- Delist date
- 2024-11-26
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.