EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
Ever Fortune.Ai, Co., Ltd. · Radiology
Open FDA's page for this record- Third party flag
- N
- City
- Taichung City
- Advisory committee description
- Radiology
- Address 1
- 8f. # 360, Sec.1 Jingmao Rd., Beitun Dist.
- Statement or summary
- Summary
- Product code
- QAS
- Zip code
- 406040
- Applicant
- Ever Fortune.Ai, Co., Ltd.
- Decision date
- 2025-02-20
- Decision code
- SESE
- Country code
- TW
- Device name
- EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
- Advisory committee
- RA
- Contact
- Chang Joseph
- K number
- K242821
- Date received
- 2024-09-18
- Review advisory committee
- RA
- Postal code
- 406040
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Radiological Computer-Assisted Triage And Notification Software
- Medical specialty description
- Radiology
- Regulation number
- 892.2080
- Device class
- 2
- Registration number
- 3021915828, 3021032044, 3017604664, 3014938447, 3017840913, 3014665798, 3015763655, 3016727312, 3011205675, 3035495311, 3017210169, 3007301305, 3023702863, 3012453401, 3034656245, 3014678441, 3017489096, 3004977335, 3038177848
- FEI number
- 3021915828, 3021032044, 3017604664, 3014938447, 3017840913, 3014665798, 3015763655, 3016727312, 3035495311, 3017210169, 3007301305, 3023702863, 3012453401, 3034656245, 3014678441, 3017489096, 3004977335, 3014269683, 3038177848