XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION— 510(k) K130884

Name: FDA 510(k) clearance K130884
Creator: U.S. Food and Drug Administration
Published: 2013-04-12

Substantially Equivalent

Ge Medical Systems F.I. Haifa

FDA 510(k) clearance K130884 for XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION, Substantially Equivalent on 2013-04-12. Applicant: Ge Medical Systems F.I. Haifa. Device class: 2.

Clearance details

Applicant: Ge Medical Systems F.I. Haifa
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2013-03-29
Decision date: 2013-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tirat Hacarmel, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

More clearances from Ge Medical Systems F.I. Haifa

view all

K093982 — XELERIS 3 PROCESSING AND REVIEW WORKSTATION2010-01-08
K093514 — DISCOVERY MODEL NM/CT 6702009-12-10
K083504 — GE DISCOVERY NM/CT 570C2008-12-12
K080124 — VENTRI 1.12008-01-31
K051855 — VENTRI2005-08-02

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 →

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