3D-Anywhere— 510(k) K253899

Name: FDA 510(k) clearance K253899
Creator: U.S. Food and Drug Administration
Published: 2026-07-09

Substantially Equivalent

Provect.AI

FDA 510(k) clearance K253899 for 3D-Anywhere, Substantially Equivalent on 2026-07-09. Applicant: Provect.AI. Device class: 2.

Summary

3D-Anywhere from Provect.AI is filed under LLZ, radiological image processing systems. The record doesn't describe what the product does beyond that code name.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it was a Traditional 510(k).

Provect.AI filed from Los Gatos, California. Review took 216 calendar days (December 5, 2025 to July 9, 2026).

Clearance details

Applicant: Provect.AI
Product code: Product code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-12-05
Decision date: 2026-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Gatos, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.