510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K251022Substantially Equivalent

3D-Shaper

3D-Shaper Medical S.L., Barcelona, ES / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251022 is the FDA 510(k) clearance record for 3D-SHAPER, a class II device, cleared for 3D-Shaper Medical S.L on under FDA product code KGI (Densitometer, Bone). FDA records list 2 510(k) clearances for 3D-Shaper Medical S.L, from to . As of , FDA records show no recalls naming K251022.

Clearance record

Decision date
Received
(156 days to decision)
Product code
KGI Densitometer, Bone
Regulation
21 CFR 892.1170
Device class
Class II
Review panel
Radiology
Applicant
3D-Shaper Medical S.L Rambla Catalunya, 53, 4-H, Barcelona, ES
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KGI

Trailing 12 months
2 clearances under product code KGI in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KGI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260