Class Class II

3D-SHAPER (K251022)

K251022 2025-09-05 Traditional
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Description

3D-SHAPER by 3D-Shaper Medical S.L, an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251022
Clearance Date2025-09-05
Clearance TypeTraditional
Product CodeKGI
Regulation Number892.1170

Categories

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