DeviceClearance

EPIQ 5 Diagnostic Ultrasound System +3 more— 510(k) K163120

Substantially Equivalent

Philips Ultrasound, Inc.

FDA 510(k) clearance K163120 for EPIQ 5 Diagnostic Ultrasound System +3 more, Substantially Equivalent on 2017-01-10. Applicant: Philips Ultrasound, Inc.. Device class: 2.

Clearance details

Device name as filed
EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System
Applicant
Philips Ultrasound, Inc.
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 ↗

Recent devices under product code IYN

view all

More clearances from Philips Ultrasound, Inc.

view all

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 K163120

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 K163120.

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