Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)
Edan Instruments, Inc. · Radiology
Open FDA's page for this record- Third party flag
- Y
- City
- Shenzhen
- Advisory committee description
- Radiology
- Address 1
- 15 Jinhui Rd., Jinsha Community, Kengzi Sub-District,
- Address 2
- Pingshan District,
- Statement or summary
- Summary
- Product code
- IYN
- Zip code
- 518122
- Applicant
- Edan Instruments, Inc.
- Decision date
- 2025-02-20
- Decision code
- SESE
- Country code
- CN
- Advisory committee
- RA
- Contact
- Tracy Yue
- K number
- K250214
- Date received
- 2025-01-24
- Review advisory committee
- RA
- Postal code
- 518122
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Device name
Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)
- Harmonized identifiers (openFDA)
- Device name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Medical specialty description
- Radiology
- Regulation number
- 892.1550
- Device class
- 2
- Registration number
- 1000602763, 3005403518, 3003600763, 3005406110, 3018094310, 9710090, 3003774756, 1062741, 3008487708, 3008729547, 1000513161, 2518897, 3014555455, 8010047, 3010703925, 3003589956, 3017955833, 9616774, 3009499478, 9680269, 3003899230, 3010663777, 2521877, 3010398867, 3003681187, 3005334138, 3003637092, 3011686611, 3016436764, 1054713, 2134812, 3016493665, 3010390468, 3026047529, 3003412859, 3002808148, 3009196578, 3015806723, 3011137372, 3009156722 +182 more
- FEI number
- 1000602763, 3005403518, 3003600763, 3005406110, 3018094310, 3003774756, 3008487708, 3008729547, 1000513161, 3014555455, 3010703925, 3003309342, 3003589956, 3017955833, 3003408255, 3009499478, 3002808127, 3003899230, 1000124215, 3010663777, 2521877, 3010398867, 3003681187, 3005334138, 3003637092, 3011686611, 3002808529, 3016436764, 3002808382, 3016493665, 3010390468, 3026047529, 3003412859, 3000957797, 3002808148, 3009196578, 3015806723, 3009156722, 3027501622, 3019216 +182 more