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)

Open Rib

K-Number: K223261 · 2023-07-13

ApplicantCanon Medical Informatics, Inc.
Decision Date2023-07-13
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Open Rib is the device name listed in this FDA 510(k) record. The listed applicant is Canon Medical Informatics, Inc.. It received FDA 510(k) clearance on 2023-07-13 under 510(k) number K223261. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Open Rib?

Open Rib is a medical device that received FDA 510(k) clearance on 2023-07-13. The listed applicant is Canon Medical Informatics, Inc.. The 510(k) number is K223261.

When did Open Rib receive FDA 510(k) clearance?

Open Rib received FDA 510(k) clearance on 2023-07-13, under 510(k) number K223261.

Who is the listed applicant for Open Rib?

The FDA 510(k) record lists Canon Medical Informatics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Open Rib?

The FDA product code for Open Rib is JAK.

Other records listing Canon Medical Informatics, 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.

K260324Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) PlanningK252217CT VScore+K243240Vitrea CT VScoreK222662Vitrea CT Cardiac Analysis

Related Devices (Code: JAK)

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.

K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLCK253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems CorporationK253649Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd.

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.

↑