Cleared Traditional

NewTom 5G XL

K183448 · Cefla S.C. · Radiology
Mar 2019
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K183448 is an FDA 510(k) clearance for the NewTom 5G XL, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Cefla S.C. (Imola (Bo), IT). The FDA issued a Cleared decision on March 8, 2019, 86 days after receiving the submission on December 12, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K183448 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2018
Decision Date March 08, 2019
Days to Decision 86 days
Submission Type Traditional
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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