DeviceClearance

6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System— 510(k) K161359

Substantially Equivalent

Esaote, S.p.A.

FDA 510(k) clearance K161359 for 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System, Substantially Equivalent on 2016-07-19. Applicant: Esaote, S.p.A.. Device class: 2.

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
Genova, IT
Download summary PDFView on FDA.gov ↗

Recent devices under product code IYN

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More clearances from Esaote, S.p.A.

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Adverse 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 →

Recalls naming K161359

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161359.

Data sourced from openFDA. This site is unofficial and independent of the FDA.