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FDA 510(k)

iExaminer System with Panoptic Plus

K-Number: K223381 · 2023-03-15

ApplicantWelch Allyn, Inc.
Decision Date2023-03-15
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

iExaminer System with Panoptic Plus is a medical device manufactured by Welch Allyn, Inc.. It received FDA 510(k) clearance on 2023-03-15 under approval number K223381. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iExaminer System with Panoptic Plus?

iExaminer System with Panoptic Plus is a medical device that received FDA 510(k) clearance on 2023-03-15. It is manufactured by Welch Allyn, Inc.. The 510(k) number is K223381.

When was iExaminer System with Panoptic Plus approved by the FDA?

iExaminer System with Panoptic Plus received FDA 510(k) clearance on 2023-03-15, under approval number K223381.

What company makes iExaminer System with Panoptic Plus?

iExaminer System with Panoptic Plus is manufactured by Welch Allyn, Inc..

What is the FDA product code for iExaminer System with Panoptic Plus?

The FDA product code for iExaminer System with Panoptic Plus is HKI.

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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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