Cleared Traditional

aprevo? Digital Planning

K242599 · Carlsmed, Inc. · Radiology
Dec 2024
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K242599 is an FDA 510(k) clearance for the aprevo? Digital Planning, 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 20, 2024, 112 days after receiving the submission on August 30, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K242599 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2024
Decision Date December 20, 2024
Days to Decision 112 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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