Company profile

Esaote, S.p.A.

Esaote, S.p.A. has 7 AI-enabled medical devices on the FDA list. The first decision was on November 29, 2023 and the most recent on April 6, 2026 (6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)). Its most common review panel is Radiology (7 devices).

7AI devices
2023First decision
2026Latest decision
1Specialties

Per year

2023: 12025: 32026: 3
202320252026
Esaote, S.p.A. AI devices per year: 2023 1, 2025 3, 2026 3

By specialty

  • Radiology7

Related guides

Top radiology devices

Timeline

  1. 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) · Radiology · IYN
  2. S-scan Open (100001800) · Radiology · LNH
  3. Magnifico Open (100009900) · Radiology · LNH
  4. 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) · Radiology · IYN
  5. 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) · Radiology · IYN
  6. 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) · Radiology · IYN
  7. 6440 MyLabX90 · Radiology · IYN