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FDA 510(k)

OnSight 3D Extremity System

K-Number: K173478 · 2018-01-19

ApplicantCarestream Health, Inc.
Decision Date2018-01-19
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OnSight 3D Extremity System is a medical device manufactured by Carestream Health, Inc.. It received FDA 510(k) clearance on 2018-01-19 under approval number K173478. 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 OnSight 3D Extremity System?

OnSight 3D Extremity System is a medical device that received FDA 510(k) clearance on 2018-01-19. It is manufactured by Carestream Health, Inc.. The 510(k) number is K173478.

When was OnSight 3D Extremity System approved by the FDA?

OnSight 3D Extremity System received FDA 510(k) clearance on 2018-01-19, under approval number K173478.

What company makes OnSight 3D Extremity System?

OnSight 3D Extremity System is manufactured by Carestream Health, Inc..

What is the FDA product code for OnSight 3D Extremity System?

The FDA product code for OnSight 3D Extremity System is JAK.

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Other Devices by Carestream Health, Inc.

K163203Carestream DRX-Evolution K160723OnSight 3D Extremity System K153103CARESTREAM Vue PACS K170755DRX-Revolution Nano Mobile X-ray System K170580Carestream Vue PACS K180809Eclipse II

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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.

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