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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 the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 2023-03-15 under 510(k) 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. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K223381.

When did iExaminer System with Panoptic Plus receive FDA 510(k) clearance?

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

Who is the listed applicant for iExaminer System with Panoptic Plus?

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

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

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

Other records listing Welch Allyn, Inc. as applicant

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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Related Devices (Code: 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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