Chest / ThoracicDevices & AI clearances

Gleamer's ChestView US 1.1 Receives FDA 510(k) Clearance

U.S. FDA1w ago

FDA grants 510(k) clearance to Gleamer's ChestView US 1.1, a lung ultrasound device (product code MYN, Radiology committee).

  • Cleared under 510(k) pathway; classified as product code MYN, a pulsed echo ultrasound imaging system.
  • Device applicant: Gleamer; version 1.1.
Read the source

Automated summary

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