GeneralDevices & AI clearances

FDA clears Airs Medical's SwiftMR MRI system

U.S. FDA1w ago

U.S. FDA granted 510(k) clearance to Airs Medical, Inc. for SwiftMR, a magnetic resonance imaging (MRI) system (product code QIH).

  • The clearance fell under the Radiology committee and the 510(k) pathway.
  • Product code QIH identifies the device as a nuclear magnetic resonance imaging system.
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