DeviceClearance

ECHO TRUE 3D VIEWER— 510(k) K142107

Substantially Equivalent

Echopixel, Inc.

FDA 510(k) clearance K142107 for ECHO TRUE 3D VIEWER, Substantially Equivalent on 2015-01-21. Applicant: Echopixel, Inc.. Device class: 2.

Clearance details

Applicant
Echopixel, Inc.
Product code
Code LLZ
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mountain View, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

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 K142107

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 K142107.

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