FDA 510(k)

3D-Anywhere

K-Number: K253899 · 2026-07-09

Decision Date2026-07-09

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

3D-Anywhere is the device name listed in this FDA 510(k) record. The listed applicant is Provect.AI. It received FDA 510(k) clearance on 2026-07-09 under 510(k) number K253899. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3D-Anywhere?

3D-Anywhere is a medical device that received FDA 510(k) clearance on 2026-07-09. The listed applicant is Provect.AI. The 510(k) number is K253899.

When did 3D-Anywhere receive FDA 510(k) clearance?

3D-Anywhere received FDA 510(k) clearance on 2026-07-09, under 510(k) number K253899.

Who is the listed applicant for 3D-Anywhere?

The FDA 510(k) record lists Provect.AI as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3D-Anywhere?

The FDA product code for 3D-Anywhere is LLZ.

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.