GeneralDevices & AI clearances

FDA clears MEDA's MD-6000S bladder scanner

U.S. FDA1w ago

MEDA Co., Ltd. received FDA 510(k) clearance for the MD-6000S bladder scanner, a noninvasive ultrasound device for bladder volume assessment (product code IYO).

  • FDA cleared the MD-6000S Bladder Scanner via the 510(k) pathway under product code IYO.
  • The device is manufactured by MEDA Co., Ltd. and is intended for noninvasive bladder volume measurement.

Automated summary

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