FDA 510(k)

REAL INTELLIGENCE™ CORI™ XT (CORI XT)

Número K: K252841 · 2025-12-05

Data da decisão2025-12-05

Código do produtoOLO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Blue Belt Technologies, Inc. como candidato(a)

K260601REAL INTELLIGENCE™ CORI™K250921CORIOGRAPH Pre-Op Planning and Modeling Services K242272CORIOGRAPH Pre-Op Planning and Modeling Services K240139Real Intelligence™ CORI™K231963REAL INTELLIGENCE™ CORI™K221224REAL INTELLIGENCE CORI

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