Cleared Special

LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW

K023332 · GE Medical Systems · Radiology
Oct 2002
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K023332 is an FDA 510(k) clearance for the LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on October 23, 2002, 16 days after receiving the submission on October 7, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K023332 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 2002
Decision Date October 23, 2002
Days to Decision 16 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAK — System, X-ray, Tomography, Computed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750

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