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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, imaging, esophageal, wireless, capsule
Regulation Description Ingestible telemetric gastrointestinal capsule imaging system.
Definition THE CAPSULE IS A DISPOSABLE, INGESTIBLE CAPSULE DESIGNED TO ACQUIRE VIDEO IMAGES OF THE ESOPHAGUS. THE CAPSULE TRANSMITS THE ACQUIRED IMAGES VIA RF COMMUNICATION CHANNEL TO A DATA RECORDER LOCATED OUTSIDE THE BODY. THE DIAGNOSTIC IMAGING SYSTEM IS INTENDED FOR VISUALIZATION OF THE ESOPHAGUS RATHER THAN THE SMALL BOWEL.
Product CodeNSI
Regulation Number 876.1300
Device Class 2


Premarket Reviews
ManufacturerDecision
GIVEN IMAGING
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
No Known Device Problem 1
Total Device Problems 1

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