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GeneralEmergencyDevice clearance

FDA Clears Portable Digital Radiography System from Shantou Institute of Ultrasonic Instruments

FDA 510(k) — Radiology devices2w ago

FDA grants 510(k) clearance to Shantou Institute of Ultrasonic Instruments for a portable digital radiography (DR) imaging system. The device is a mobile X-ray system intended for general diagnostic imaging. (Product code IZL).

  • Portable digital radiography (DR) X-ray system cleared via FDA 510(k) (product code IZL).
  • Intended for mobile general diagnostic imaging.
  • Manufacturer: Shantou Institute of Ultrasonic Instruments Co., Ltd.
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