DeviceClearance

HD11 DIAGNOSTIC ULTRASOUND SYSTEM— 510(k) K043535

Substantially Equivalent

Philips Ultrasound, Inc.

FDA 510(k) clearance K043535 for HD11 DIAGNOSTIC ULTRASOUND SYSTEM, Substantially Equivalent on 2005-01-06. Applicant: Philips Ultrasound, Inc.. Device class: 2.

Clearance details

Applicant
Philips Ultrasound, Inc.
Product code
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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More clearances from Philips Ultrasound, Inc.

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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 K043535

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 K043535.

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