DeviceClearance

CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System— 510(k) K162329

Substantially Equivalent

Philips Health Care

FDA 510(k) clearance K162329 for CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Substantially Equivalent on 2016-09-14. 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
Bothell, WA, 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 K162329

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 K162329.

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