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510(k) DEN220024

ScanNav Anatomy Peripheral Nerve Block by Intelligent Ultrasound Limited — Product Code QRG

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
October 18, 2022
Date Received
April 8, 2022
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasound Guided Nerve Block Assist
Device Class
Class II
Regulation Number
868.1980
Review Panel
AN
Submission Type

This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia.

Other clearances by Intelligent Ultrasound Limited

  • K232787 — ScanNav Anatomy Peripheral Nerve Block (October 6, 2023)

Other clearances for product code QRG

  • K250818 — Nerveblox (August 15, 2025)
  • K232787 — ScanNav Anatomy Peripheral Nerve Block (October 6, 2023)