Medical Device Division · registration 180143ActiveACIST
Hong KongScanning Systems, Ultrasonic, IntravascularClass IIACIST Medical Systems, Inc.
Official record identity
- MDACS listing number
- 180143
- Model name
- ACIST HDi System (017986), Imagine Engine (console) (017987), Patient Interface Module (PIM) (017989), Linear Translation System (LTS) (017988), ACIST HDi Cart (017991)
- Registration date
- March 23, 2023
- Expiry date
- May 12, 2028
- Source update date
- July 09, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
Official value: II
Published parties
- Registrant / registration holder
- Pacific Medical (Hong Kong) Company Limited
- Manufacturer
- ACIST Medical Systems, Inc.
Official description
Scanning Systems, Ultrasonic, Intravascular
Additional source fields
- AMD nomenclature code
- 17746
- Local responsible person phone
- 23438009
- Published manufacturer address
- 7905 Fuller Road, Eden Prairie, Minnesota, 55344, USA
- Revision number
- a
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.