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 a medical device manufactured by Canon Medical Informatics, Inc.. It received FDA 510(k) clearance on 2023-07-13 under approval 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. It is manufactured by Canon Medical Informatics, Inc.. The 510(k) number is K223261.

When was Open Rib approved by the FDA?

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

What company makes Open Rib?

Open Rib is manufactured by Canon Medical Informatics, Inc..

What is the FDA product code for Open Rib?

The FDA product code for Open Rib is JAK.

Other Devices by Canon Medical Informatics, Inc.

K222662Vitrea CT Cardiac Analysis K252217CT VScore+ K243240Vitrea CT VScore

Related Devices (Code: JAK)

K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc. K163213Revolution CTGe Medical Systems, LLC K161157Vitrea CT Dual Energy Image ViewVital Images, Inc. K160723OnSight 3D Extremity SystemCarestream Health, Inc. K161196SOMATOM DriveSiemens Medical Solutions USA, Inc. K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc.

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.