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FDA-cleared K253288

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)

Esaote, S.p.A.

Authorized purpose: Esaote 6450 Ultrasound for MyLabE80 and MyLabE85 acquires, displays, and analyzes diagnostic ultrasound data for the labeled cardiac, vascular, general, and women's-health applications, including the described fusion functions.

Modality
Ultrasound
Anatomy
Heart; vascular; abdominal; small-organ; musculoskeletal; and women's-health anatomy
Decision
2026-04-06
FDA-cleared K260746

S-scan Open (100001800)

Esaote, S.p.A.

Authorized purpose: S-scan Open is an Esaote MR system for diagnostic image acquisition, reconstruction, display, and professional interpretation within the labeled scanner, coil, sequence, and anatomy scope.

Modality
MRI
Anatomy
Multi-region
Decision
2026-03-27
FDA-cleared K251901

Magnifico Open (100009900)

Esaote, S.p.A.

Authorized purpose: Magnifico Open is a general-purpose MRI system that acquires, displays, and analyzes MR images and real-time imaging for the labeled body regions and open-MRI applications.

Modality
MRI
Anatomy
Calf, knee, ankle, foot, thigh, hand, wrist, forearm, elbow, arm, shoulder, hip, spine, pelvis, temporomandibular joint, head, and upper abdomen
Decision
2026-03-05
FDA-cleared K253310

7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)

Esaote, S.P.A.

Authorized purpose: The 7600 Ultrasound System provides multifunctional diagnostic ultrasound imaging, analysis, Doppler, elastography, three-dimensional and four-dimensional imaging, and contrast-enhanced functions across the labeled clinical applications.

Modality
Ultrasound
Anatomy
Abdominal, cardiac, small-organ, vascular, musculoskeletal, women's-health, obstetric, gynecologic, transrectal, and transvaginal anatomy
Decision
2025-11-25
FDA-cleared K243253

6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)

Esaote S.p.A.

Authorized purpose: The 6600 Ultrasound System is a multifunctional diagnostic ultrasound scanner that collects, displays, and analyzes ultrasound images during ultrasound imaging procedures with supported echographic probes across the labeled cardiac, vascular, general-imaging, invasive, and women-health applications.

Modality
Ultrasound
Anatomy
Heart, vascular, abdominal, breast, musculoskeletal, small-organ, thyroid, urologic, pelvic, fetal, gynecologic, and transesophageal anatomy
Decision
2025-06-18
FDA-cleared K241671

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)

Esaote S.p.A.

Authorized purpose: The 6450 Ultrasound System is a multifunctional diagnostic ultrasound scanner for collecting, displaying, and analyzing ultrasound images with supported probes; Virtual Navigator can display ultrasound with a second modality for additional morphology information in the labeled workflow.

Modality
Ultrasound
Anatomy
Heart, vascular, abdominal, breast, musculoskeletal, small-organ, thyroid, urologic, pelvic, fetal, gynecologic, and transesophageal anatomy
Decision
2025-05-16
FDA-cleared K230179

6440 MyLabX90

Esaote S.p.A.

Authorized purpose: 6440 MyLabX90 is a general-purpose diagnostic ultrasound system for labeled imaging and fluid-flow applications; exact probes, modes, anatomies, and patient populations require submission-specific confirmation.

Modality
Ultrasound
Anatomy
Multi-region
Decision
2023-11-29