Universal Viewer— 510(k) K211312

Name: FDA 510(k) clearance K211312
Creator: U.S. Food and Drug Administration
Published: 2021-05-21

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K211312 for Universal Viewer, Substantially Equivalent on 2021-05-21. 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: 2021-04-30
Decision date: 2021-05-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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More clearances from GE Healthcare

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K253639 — View2026-01-08
K242925 — MR Contour DL2025-04-01
K232346 — Digital Expert Access with Remote Scanning2023-10-27
K223212 — Precision DL2023-04-27
K221680 — Xeleris V Processing and Review System2023-03-01

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 K211312

K-number listed on FDA's recall record

Z-0143-2024 — Universal Viewer Workflow Manager, Image processing radiological systemClass II·Ongoing·GE Healthcare·20230908
Z-1566-2022 — (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.Class II·Ongoing·GE Healthcare, LLC·20220715

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K211312.

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