DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)— 510(k) K132261

Name: FDA 510(k) clearance K132261
Creator: U.S. Food and Drug Administration
Published: 2013-11-18

Substantially Equivalent

Ge Medical Systems, LLC

FDA 510(k) clearance K132261 for DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS), Substantially Equivalent on 2013-11-18. Applicant: Ge Medical Systems, LLC. Device class: 2.

Clearance details

Applicant: Ge Medical Systems, LLC
Product code: Code IZF
Device class: Class 2
Regulation: 21 CFR 892.1740
Advisory panel: Radiology
Date received: 2013-07-19
Decision date: 2013-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K132261

K-number listed on FDA's recall record

Z-2291-2014 — GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages.Class II·Terminated·GE Healthcare, LLC·20140725

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132261.

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