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FDA 510(k)

Interlocked Circular Small Field Collimators, Elekta Integrated

K-Number: K161984 · 2016-09-27

ApplicantAktina Medical Corporation
Decision Date2016-09-27
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Interlocked Circular Small Field Collimators, Elekta Integrated is a medical device manufactured by Aktina Medical Corporation. It received FDA 510(k) clearance on 2016-09-27 under approval number K161984. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Interlocked Circular Small Field Collimators, Elekta Integrated?

Interlocked Circular Small Field Collimators, Elekta Integrated is a medical device that received FDA 510(k) clearance on 2016-09-27. It is manufactured by Aktina Medical Corporation. The 510(k) number is K161984.

When was Interlocked Circular Small Field Collimators, Elekta Integrated approved by the FDA?

Interlocked Circular Small Field Collimators, Elekta Integrated received FDA 510(k) clearance on 2016-09-27, under approval number K161984.

What company makes Interlocked Circular Small Field Collimators, Elekta Integrated?

Interlocked Circular Small Field Collimators, Elekta Integrated is manufactured by Aktina Medical Corporation.

What is the FDA product code for Interlocked Circular Small Field Collimators, Elekta Integrated?

The FDA product code for Interlocked Circular Small Field Collimators, Elekta Integrated is IYE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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