Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
FDA 510(k) K181016 · Welch Allyn, Inc.
510(k) numberK181016
Submission
- Device name
- Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
- Applicant
- Welch Allyn, Inc.
Skaneateles Falls, NY, US - Received
- April 17, 2018
- Decision date
- July 16, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System cleared by the FDA?
Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System (K181016) received a 510(k) decision of Substantially Equivalent on July 16, 2018, 90 days after the submission was received.
What is the product code of K181016?
The FDA product code is NFJ – System, Image Management, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 892.2050.