Cleared Traditional

Spectral Bone Marrow

K223514 · Ge Medical Systems, LLC · Radiology
Mar 2023
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K223514 is an FDA 510(k) clearance for the Spectral Bone Marrow, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on March 9, 2023, 107 days after receiving the submission on November 22, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K223514 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2022
Decision Date March 09, 2023
Days to Decision 107 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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