CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT— 510(k) K131977

Name: FDA 510(k) clearance K131977
Creator: U.S. Food and Drug Administration
Published: 2013-09-17

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K131977 for CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT, Substantially Equivalent on 2013-09-17. Applicant: GE Healthcare. Device class: 2.

Clearance details

Applicant: GE Healthcare
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2013-06-28
Decision date: 2013-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barrington, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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 K131977

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 K131977.

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