FDA 510(k)

Sistema de Ultrasonido 6450 (MyLabE80); Sistema de Ultrasonido 6450 (MyLabE85)

N.º K: K253288 · 2026-04-06

Fecha de decisión2026-04-06

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2026-04-06 under 510(k) number K253288. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)?

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) is a medical device that received FDA 510(k) clearance on 2026-04-06. The listed applicant is Esaote, S.p.A.. The 510(k) number is K253288.

When did 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) receive FDA 510(k) clearance?

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) received FDA 510(k) clearance on 2026-04-06, under 510(k) number K253288.

Who is the listed applicant for 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)?

The FDA 510(k) record lists Esaote, S.p.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)?

The FDA product code for 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) is IYN.

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Otros registros que enlistan a Esaote, S.p.A. como solicitante

K261331I-Genius (100019400)K260746S-scan Open (100001800)K251901Magnifico Open (100009900)K253310Sistema de Ultrasonido 7600 (MyLabC25); Sistema de Ultrasonido 7600 (MyLabC30)K243253Sistema de Ultrasonido 6600 (MyLabA50); Sistema de Ultrasonido 6600 (MyLabA70)K241671Sistema de Ultrasonido 6450 (MyLabE80); Sistema de Ultrasonido 6450 (MyLabE85)

Ver todos los 25 dispositivos →

Dispositivos relacionados (Código: IYN)

Fuente oficial

Ver en la base de datos de la FDA →

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