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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device home monitoring ophthalmic optical coherence tomography (oct) imaging device
Definition A home monitoring ophthalmic imaging device is a prescription self-imaging device that incorporates imaging system hardware and automated image processing and analysis to enable patients at home to provide measurements that are intended for use by a physician for monitoring ophthalmic diseases or conditions in between regularly scheduled assessments.
Product CodeSAX
Regulation Number 886.1600
Device Class 2


Premarket Reviews
ManufacturerDecision
NOTAL VISION, INC.
  GRANTED 1

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