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FDA 510(k)

Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System

K-Number: K181016 · 2018-07-16

ApplicantWelch Allyn, Inc.
Decision Date2018-07-16
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System 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 2018-07-16 under 510(k) number K181016. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System?

Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System is a medical device that received FDA 510(k) clearance on 2018-07-16. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K181016.

When did Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System receive FDA 510(k) clearance?

Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System received FDA 510(k) clearance on 2018-07-16, under 510(k) number K181016.

Who is the listed applicant for Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System?

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 Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System?

The FDA product code for Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System is NFJ.

Other records listing Welch Allyn, Inc. as applicant

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Related Devices (Code: NFJ)

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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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