VinDr-Mammo
Vinbigdata Joint Stock Company · Radiology
Open FDA's page for this record- Third party flag
- N
- City
- Ha Noi
- Advisory committee description
- Radiology
- Address 1
- Symphony Office Bldg., Chu Huy Man St.,
- Address 2
- Vinhomes Riverside Ecological Urban Area
- Statement or summary
- Summary
- Product code
- QFM
- Zip code
- 100000
- Applicant
- Vinbigdata Joint Stock Company
- Decision date
- 2024-05-23
- Decision code
- SESE
- Country code
- VN
- Device name
- VinDr-Mammo
- Advisory committee
- RA
- Contact
- Nguyet (Jun) Phan
- K number
- K233108
- Date received
- 2023-09-27
- Review advisory committee
- RA
- Postal code
- 100000
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Radiological Computer-Assisted Prioritization Software For Lesions
- Medical specialty description
- Radiology
- Regulation number
- 892.2080
- Device class
- 2
- Registration number
- 3021032044, 3007734888, 3024844299, 3017604664, 3014938447, 3017840913, 3014665798, 3011205675, 3034205378, 3018733944, 9616047, 3030491946, 3023702863, 3012453401, 3005156333, 3029915548, 3034656245, 3014678441, 3021230777, 3017173128, 3027453703, 2126677
- FEI number
- 3021032044, 3007734888, 3024844299, 3017604664, 3014938447, 3017840913, 3003377038, 3014665798, 3034205378, 3018733944, 3030491946, 3023702863, 3012453401, 3005156333, 3029915548, 3034656245, 3014678441, 3021230777, 3017173128, 3027453703, 3014269683, 2126677