Interventional (IR)Devices & AI clearances

FDA Clears Accurate Access ND Needle Guidance System

U.S. FDA2w ago

The FDA has cleared the ND Needle Guidance System via the 510(k) pathway for use in interventional radiology procedures.

  • The device is classified under product code ITX and was reviewed by the Radiology committee.
  • Specific performance metrics or predicate device comparisons were not publicly disclosed in the clearance record.
Read the source

Automated summary

RadPigeon summaries are original and for information only. They are not clinical advice.