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FDA 510(k)

REAL INTELLIGENCE™ CORI™ XT (CORI XT)

K-Number: K252841 · 2025-12-05

ApplicantBlue Belt Technologies, Inc.
Decision Date2025-12-05
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

REAL INTELLIGENCE™ CORI™ XT (CORI XT) is the device name listed in this FDA 510(k) record. The listed applicant is Blue Belt Technologies, Inc.. It received FDA 510(k) clearance on 2025-12-05 under 510(k) number K252841. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAL INTELLIGENCE™ CORI™ XT (CORI XT)?

REAL INTELLIGENCE™ CORI™ XT (CORI XT) is a medical device that received FDA 510(k) clearance on 2025-12-05. The listed applicant is Blue Belt Technologies, Inc.. The 510(k) number is K252841.

When did REAL INTELLIGENCE™ CORI™ XT (CORI XT) receive FDA 510(k) clearance?

REAL INTELLIGENCE™ CORI™ XT (CORI XT) received FDA 510(k) clearance on 2025-12-05, under 510(k) number K252841.

Who is the listed applicant for REAL INTELLIGENCE™ CORI™ XT (CORI XT)?

The FDA 510(k) record lists Blue Belt Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REAL INTELLIGENCE™ CORI™ XT (CORI XT)?

The FDA product code for REAL INTELLIGENCE™ CORI™ XT (CORI XT) is OLO.

Other records listing Blue Belt Technologies, Inc. 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.

K260601REAL INTELLIGENCE™ CORI™K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesK242272CORIOGRAPH Pre-Op Planning and Modeling ServicesK240139Real Intelligence™ CORI™K231963REAL INTELLIGENCE™ CORI™K221224REAL INTELLIGENCE CORI

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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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