3D-SHAPER

FDA 510(k) K220822 · 3D-Shaper Medical S.L

Substantially Equivalent

510(k) numberK220822

Submission

Device name
3D-SHAPER
Applicant
3D-Shaper Medical S.L
Barcelona, ES
Received
March 21, 2022
Decision date
December 9, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KGI – Densitometer, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1170
Specialty
Radiology

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K191112GEHC DXA Bone Densitometers with enCORE version 18KGI · Traditional GE Medical Systems Ultrasound & Primary Care…09/19/2019SE
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More from GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

510(k)DeviceDecision
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Questions and answers

When was 3D-SHAPER cleared by the FDA?

3D-SHAPER (K220822) received a 510(k) decision of Substantially Equivalent on December 9, 2022, 263 days after the submission was received.

What is the product code of K220822?

The FDA product code is KGI – Densitometer, Bone, a Class II (moderate risk) device regulated under 21 CFR 892.1170.