Real Intelligence Cori

by Blue Belt Technologies, Inc. 510(k) 4 variants

Active United States

510(k) K193120

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK193120	Date14 Feb 2020Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K193120
FDA Product Code: OLO

Device Class: Class II
Regulation: 21 CFR Part 882.4560
Advisory Committee: Neurology
FDA Decision: SESE Substantially Equivalent

Other devices from Blue Belt Technologies, Inc.

Ri.hip Modeler

Class II
CORIOGRAPH Pre-Op Planning and Modeling Services

Class II
Real Intelligence Cori

Class II
Navio

Class II
Real Intelligence™ CORI™ Open recall

Class II
Stride Unicondylar Knee

Class II

See all devices from Blue Belt Technologies, Inc. →