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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ultrasound bronchoscope
Regulation Description Ultrasonic pulsed doppler imaging system.
Definition An ultrasound bronchoscope is indicated for the ultrasonic visualization, diagnosis and therapeutic access to the bronchial tree or the lungs. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodePSV
Regulation Number 892.1550
Device Class 2


Premarket Reviews
ManufacturerDecision
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Detachment of device component 1
Material fragmentation 1
Total Device Problems 2

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