Cleared Traditional

NewTom 7G

K220664 · Cefla S.C. · Radiology
May 2022
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K220664 is an FDA 510(k) clearance for the NewTom 7G, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Cefla S.C. (Imola, IT). The FDA issued a Cleared decision on May 6, 2022, 60 days after receiving the submission on March 7, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K220664 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2022
Decision Date May 06, 2022
Days to Decision 60 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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