DeviceClearance

EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System— 510(k) K160807

Substantially Equivalent

Philips Ultrasound, Inc.

FDA 510(k) clearance K160807 for EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System, Substantially Equivalent on 2016-04-06. 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 ↗

Recent devices under product code IYN

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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 K160807

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 K160807.

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