DeviceClearance

CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM— 510(k) K120321

Substantially Equivalent

Philips Health Care

FDA 510(k) clearance K120321 for CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM, Substantially Equivalent on 2012-02-17. Applicant: Philips Health Care. Device class: 2.

Clearance details

Applicant
Philips Health Care
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
Andover, MA, US
Download summary PDFView on FDA.gov ↗

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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 K120321

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 K120321.

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