ADVANTAGE SIM MD— 510(k) K052345

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K052345 for ADVANTAGE SIM MD, Substantially Equivalent on 2005-09-14. Applicant: GE Healthcare. Device class: 2.

Clearance details

Applicant: GE Healthcare
Product code: Code KPQ
Device class: Class 2
Regulation: 21 CFR 892.5840
Advisory panel: Radiology
Date received: 2005-08-26
Decision date: 2005-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K052345

K-number listed on FDA's recall record

Z-0754-2013 — AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.Class II·Terminated·GE Healthcare, LLC·20120524

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052345.

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