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510(k) K243504

MAIA (AHMACME001) by Centervue S.P.A. — Product Code MYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2025
Date Received
November 12, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Laser, Scanning
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Other clearances by Centervue S.P.A.

  • K234076 — iCare ALTIUS CW (August 22, 2024)
  • K213705 — DRSplus (December 21, 2021)
  • K211328 — EIDON FA, EIDON, EIDON AF, EIDON UWFL (August 19, 2021)
  • K192113 — DRSplus (November 15, 2019)
  • K180526 — EIDON FA (July 16, 2018)
  • K180293 — Retia 2 (May 30, 2018)
  • K153181 — MAIA (June 8, 2016)
  • K150320 — COMPASS (June 30, 2015)
  • K142047 — EIDON (November 12, 2014)
  • K133758 — CENTERVUE MACULAR INTEGRITY ASSESSMENT (April 23, 2014)

Other clearances for product code MYC

  • K241931 — OcuMet Beacon (OCUB100) (April 22, 2025)
  • K213705 — DRSplus (December 21, 2021)
  • K211328 — EIDON FA, EIDON, EIDON AF, EIDON UWFL (August 19, 2021)
  • K192113 — DRSplus (November 15, 2019)
  • K180526 — EIDON FA (July 16, 2018)
  • K180293 — Retia 2 (May 30, 2018)
  • K153181 — MAIA (June 8, 2016)
  • K150320 — COMPASS (June 30, 2015)
  • K142897 — P200DTx (January 16, 2015)
  • K142047 — EIDON (November 12, 2014)