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FDA 510(k)

RealGUIDE

K-Number: K253902 · 2026-08-04

Applicant3DIEMME SRL
Decision Date2026-08-04
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RealGUIDE is the device name listed in this FDA 510(k) record. The listed applicant is 3DIEMME SRL. It received FDA 510(k) clearance on 2026-08-04 under 510(k) number K253902. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RealGUIDE?

RealGUIDE is a medical device that received FDA 510(k) clearance on 2026-08-04. The listed applicant is 3DIEMME SRL. The 510(k) number is K253902.

When did RealGUIDE receive FDA 510(k) clearance?

RealGUIDE received FDA 510(k) clearance on 2026-08-04, under 510(k) number K253902.

Who is the listed applicant for RealGUIDE?

The FDA 510(k) record lists 3DIEMME SRL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RealGUIDE?

The FDA product code for RealGUIDE is QIH.

Related Devices (Code: QIH)

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

View on FDA Database →

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

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