Medical Device Division · registration 241022ActiveOmni Legend
Hong KongScanning Systems, Computed Tomography/Positron Emission TomographyClass IIIGE Medical Systems, LLC
Official record identity
- MDACS listing number
- 241022
- Model name
- Omni Legend
- Registration date
- September 02, 2024
- Expiry date
- September 01, 2029
- Source update date
- November 03, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
- Published category
- Scanning Systems, Computed Tomography/Positron Emission Tomography
Official value: III
Published parties
- Registrant / registration holder
- GE Medical Systems Hong Kong Limited
- Manufacturer
- GE Medical Systems, LLC
Official description
Scanning Systems, Computed Tomography/Positron Emission Tomography
Additional source fields
- AMD nomenclature code
- 20161
- Local responsible person phone
- 21006300
- Published manufacturer address
- 3000 North Grandview Blvd, WAUKESHA, WI 53188, UNITED STATES
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.