Cleared Traditional

3D-SHAPER

K220822 · 3D-Shaper Medical S.L · Radiology
Dec 2022
Decision
263d
Days
Class 2
Risk

About This 510(k) Submission

K220822 is an FDA 510(k) clearance for the 3D-SHAPER, a Densitometer, Bone (Class II — Special Controls, product code KGI), submitted by 3D-Shaper Medical S.L (Barcelona, ES). The FDA issued a Cleared decision on December 9, 2022, 263 days after receiving the submission on March 21, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1170.

Submission Details

510(k) Number K220822 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2022
Decision Date December 09, 2022
Days to Decision 263 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KGI — Densitometer, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1170