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510(k) K181016

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2018
Date Received
April 17, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Management, Ophthalmic
Device Class
Class II
Regulation Number
892.2050
Review Panel
OP
Submission Type

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  • K142356 — Connex Spot Monitor,901058 Vital Signs Monitor Core (December 19, 2014)
  • K141582 — CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION (July 11, 2014)
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  • K132808 — VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR (November 20, 2013)

Other clearances for product code NFJ

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  • K232944 — CALLISTO eye (December 21, 2023)
  • K232555 — Harmony (November 20, 2023)
  • K231676 — CALLISTO eye (August 28, 2023)
  • K232088 — Altris IMS (July 31, 2023)
  • K220929 — Excelsior (October 31, 2022)
  • K213527 — FORUM (August 15, 2022)
  • K211715 — RetinAI Discovery (April 28, 2022)
  • K210396 — Harmony Referral System (September 13, 2021)