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510(k) K222359

Quicktome Software Suite by Omniscient Neurotechnology Pty Ltd (O8t) — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2023
Date Received
August 4, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Omniscient Neurotechnology Pty Ltd (O8t)

  • K203518 — Quicktome (March 9, 2021)

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