Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TRIOS Dx (R1)

K-Number: K260082 · 2026-04-10

Applicant3Shape TRIOS A/S
Decision Date2026-04-10
Product CodeSHQ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRIOS Dx (R1) is the device name listed in this FDA 510(k) record. The listed applicant is 3Shape TRIOS A/S. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K260082. The device is classified under product code SHQ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIOS Dx (R1)?

TRIOS Dx (R1) is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is 3Shape TRIOS A/S. The 510(k) number is K260082.

When did TRIOS Dx (R1) receive FDA 510(k) clearance?

TRIOS Dx (R1) received FDA 510(k) clearance on 2026-04-10, under 510(k) number K260082.

Who is the listed applicant for TRIOS Dx (R1)?

The FDA 510(k) record lists 3Shape TRIOS A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIOS Dx (R1)?

The FDA product code for TRIOS Dx (R1) is SHQ.

Other records listing 3Shape TRIOS A/S as applicant

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.

K242103TRIOS Ready TipK221249L1P-1F (TRIOS 5)

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.

↑