FDA-cleared K230179
6440 MyLabX90
Esaote S.p.A.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-11-29
Vendor
Esaote S.p.A.
4 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K241671
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
Esaote S.p.A.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-05-16
FDA-cleared K243253
6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)
Esaote S.p.A.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-06-18
FDA-cleared K253310
7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
Esaote, S.P.A.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-11-25