FDA 510(k)

ArcScan Insight 100

K-Number: K153416 · 2016-02-02

Decision Date2016-02-02

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ArcScan Insight 100 is the device name listed in this FDA 510(k) record. The listed applicant is Arcscan, Inc.. It received FDA 510(k) clearance on 2016-02-02 under 510(k) number K153416. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ArcScan Insight 100?

ArcScan Insight 100 is a medical device that received FDA 510(k) clearance on 2016-02-02. The listed applicant is Arcscan, Inc.. The 510(k) number is K153416.

When did ArcScan Insight 100 receive FDA 510(k) clearance?

ArcScan Insight 100 received FDA 510(k) clearance on 2016-02-02, under 510(k) number K153416.

Who is the listed applicant for ArcScan Insight 100?

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

What is the FDA product code for ArcScan Insight 100?

The FDA product code for ArcScan Insight 100 is IYO.

Related Devices (Code: IYO)

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.

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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.