Philips
Hong KongScanning Systems, UltrasonicClass IIPhilips Ultrasound, Inc.
Official record identity
- MDACS listing number
- 150094
- Model name
- Affiniti 70 Diagnostic Ultrasound System (Includes Affiniti 70C, 70G and 70W), Affiniti 50 Diagnostic Ultrasound System (Includes Affiniti 50C, 50G and 50W), Ultrasound transducer (3D9-3v, BP10-5ec, C5-1, C6-2, C8-5, C9-2, C9-4v, C10-3v, C10-4ec, L12-3, L-12-4, L12-5 50/L12-5, eL18-4, eL18-4 EMT, L18-5, mC7-2, S4-2, S5-1, S7-3t, S8-3, S8-3t, S12-4, V6-2, V9-2, VL13-5, X5-1, X7-2t), Transducer, Non-imaging (D2cwc, D2tcd, D5cwc), Surgical ultrasound imaging transducer (L15-7io), Planer Field Generator (989605418833), Table Top Field Generator (989605420101), Planer Field Generator Stand (989605464231), PercuNav Patient Tracker (10001), PercuNav Ultrasound Tracker (20004), PercuNav Adaptive Needle Tracker (41001), PercuNav Endocavity Ultrasound Tracker (21001), PercuNav Coaxial Needle Tracker (989605427983, 989605427993, 989605428003, 989605428013, 989605428023, 989605428033, 989605428043, 989605428053, 989605428063), Footswitch (989605375262)
- Registration date
- September 01, 2022
- Expiry date
- April 30, 2025
- Source update date
- March 06, 2025
- Status
- Expired
Classification
- Risk class
- Class II
Official value: II
Published parties
- Registrant / registration holder
- Philips Electronics Hong Kong Limited
- Manufacturer
- Philips Ultrasound, Inc.
Official description
Scanning Systems, Ultrasonic
Additional source fields
- AMD nomenclature code
- 14278
- Traditional Chinese local responsible person
- 飛利浦電子香港有限公司
- Local responsible person phone
- 28215888
- Published manufacturer address
- 22100 Bothell Everett Highway, Bothell, Washington 98021-8431, USA
- Published remarks
- Expired.
- Revision number
- c
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.