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FDA 510(k)

OnSight 3D Extremity System

K-Number: K160723 · 2016-08-30

ApplicantCarestream Health, Inc.
Decision Date2016-08-30
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OnSight 3D Extremity System is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health, Inc.. It received FDA 510(k) clearance on 2016-08-30 under 510(k) number K160723. 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 2016-08-30. The listed applicant is Carestream Health, Inc.. The 510(k) number is K160723.

When did OnSight 3D Extremity System receive FDA 510(k) clearance?

OnSight 3D Extremity System received FDA 510(k) clearance on 2016-08-30, under 510(k) number K160723.

Who is the listed applicant for OnSight 3D Extremity System?

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

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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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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