Cleared Traditional

aprevo? Digital Workflow

K222195 · Carlsmed, Inc. · Radiology
Dec 2022
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K222195 is an FDA 510(k) clearance for the aprevo? Digital Workflow, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Carlsmed, Inc. (Carlsbad, US). The FDA issued a Cleared decision on December 30, 2022, 161 days after receiving the submission on July 22, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K222195 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 2022
Decision Date December 30, 2022
Days to Decision 161 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050

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