CENTRICITY PACS-IW— 510(k) K121387

Name: FDA 510(k) clearance K121387
Creator: U.S. Food and Drug Administration
Published: 2012-06-05

Substantially Equivalent

Ge Healthcare Integrated IT Solutions

FDA 510(k) clearance K121387 for CENTRICITY PACS-IW, Substantially Equivalent on 2012-06-05. Applicant: Ge Healthcare Integrated IT Solutions. Device class: 2.

Clearance details

Applicant: Ge Healthcare Integrated IT Solutions
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2012-05-08
Decision date: 2012-06-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Barrington, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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More clearances from Ge Healthcare Integrated IT Solutions

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K112570 — CENTRICITY CARDIO IMAGING2011-11-30
K111614 — CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE2011-09-26
K063628 — CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY2006-12-26

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 K121387

K-number listed on FDA's recall record

Z-0023-2016 — Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.Class II·Terminated·GE Healthcare·20150916

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121387.

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