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 a medical device manufactured by Welch Allyn, Inc.. It received FDA 510(k) clearance on 2018-07-16 under approval 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. It is manufactured by Welch Allyn, Inc.. The 510(k) number is K181016.
When was Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System approved by the FDA?
Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System received FDA 510(k) clearance on 2018-07-16, under approval number K181016.
What company makes Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System?
Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System is manufactured by Welch Allyn, Inc..
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.
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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.