Cleared Traditional

K251022 - 3D-SHAPER (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251022 · 3D-Shaper Medical S.L · Radiology device
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Sep 2025
Decision
156d
Days
Class 2
Risk

K251022 is an FDA 510(k) clearance for the 3D-SHAPER. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by 3D-Shaper Medical S.L (Barcelona, ES). The FDA issued a Cleared decision on September 5, 2025 after a review of 156 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1170 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all 3D-Shaper Medical S.L devices

Submission Details

510(k) Number K251022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2025
Decision Date September 05, 2025
Days to Decision 156 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 107d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KGI Densitometer, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1170
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KGI Densitometer, Bone

All 146
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K251022.
Lunar Astra
K252718 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Apr 2026
BunkerHill BMD
K242295 · BunkerHill Health · Apr 2025
TBS iNsight (V4)
K243218 · Medimaps Group SA · Jan 2025
VirtuOst
K220402 · O.N. Diagnostics · May 2023
3D-SHAPER
K220822 · 3D-Shaper Medical S.L · Dec 2022
ABMD Software
K213760 · HeartLung Corporation · Jul 2022