510(k) K181016

Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System by Welch Allyn, Inc. — Product Code NFJ

K181016 is an FDA 510(k) premarket notification submitted by Welch Allyn, Inc. for the device "Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System". The FDA issued a decision of Substantially Equivalent on July 16, 2018. The device falls under product code NFJ (System, Image Management, Ophthalmic), a Class II device regulated under 21 CFR 892.2050. Welch Allyn, Inc. has at least 10 other 510(k) clearances on record.