Name: Predicase
Price: 199 USD

K-number	K251532
Device name	Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
Applicant	Mighty Oak Medical
Product code	LLZ
Device class	Class II
Decision date	Nov 3, 2025
Decision	Substantially Equivalent
Regulation	892.2050

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

Everything you need for a 510(k) submission. Nothing you don't.