Cleared Traditional

Precision DL

K223212 · Ge Healthcare · Radiology
Apr 2023
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K223212 is an FDA 510(k) clearance for the Precision DL, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by Ge Healthcare (Tirat Hacarmel, IL). The FDA issued a Cleared decision on April 27, 2023, 192 days after receiving the submission on October 17, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K223212 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 2022
Decision Date April 27, 2023
Days to Decision 192 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPS — System, Tomography, Computed, Emission
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1200

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