6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)— 510(k) K253288
Substantially EquivalentEsaote, S.p.A.
FDA 510(k) clearance K253288 for 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85), Substantially Equivalent on 2026-04-06. Applicant: Esaote, S.p.A.. Device class: 2.
Summary
Esaote's record names the 6450 Ultrasound System in two versions, MyLabE80 and MyLabE85, filed under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). The record doesn't say how the two differ.
Class II, 21 CFR 892.1550. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Esaote filed from Genoa, Italy. The decision came 189 calendar days after FDA received it (September 29, 2025 to April 6, 2026).
Clearance details
- Applicant
- Esaote, S.p.A.
- Product code
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Genoa, IT
Recent devices under product code IYN
view all- K261585 — Diagnostic Ultrasound System (Nuewa A20W) +10 more
- K261617 — Diagnostic Ultrasound System (11+ models)
- K263150 — V10 Diagnostic Ultrasound System +10 more
- K261933 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
- K262548 — EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
More clearances from Esaote, S.p.A.
view allAdverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.