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FDA 510(k)

ArcScan Insight 100

K-Number: K153416 · 2016-02-02

ApplicantArcscan, Inc.
Decision Date2016-02-02
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ArcScan Insight 100 is a medical device manufactured by Arcscan, Inc.. It received FDA 510(k) clearance on 2016-02-02 under approval 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. It is manufactured by Arcscan, Inc.. The 510(k) number is K153416.

When was ArcScan Insight 100 approved by the FDA?

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

What company makes ArcScan Insight 100?

ArcScan Insight 100 is manufactured by Arcscan, Inc..

What is the FDA product code for ArcScan Insight 100?

The FDA product code for ArcScan Insight 100 is IYO.

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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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