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3D Diagnostix, Inc.

FDA Regulatory Profile

3D Diagnostix, Inc. has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Nov 21, 2025 · VAI
Latest 510(k)
Dec 22, 2020

Updated: recalls Oct 23, 2026 · inspections Oct 23, 2026 · compliance actions Oct 23, 2026.

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Summary

Recalls
0
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Nov 21, 2025Allston, MADevicesVoluntary Action Indicated (VAI)3011429437

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K200908iSMILEDec 22, 2020
K202465Night GuardNov 25, 2020

FDA data resources