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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, nuclear magnetic resonance spectroscopic
Product CodeLNI
Regulation Number 892.1000
Device Class 2


Premarket Reviews
ManufacturerDecision
HITACHI MEDICAL SYSTEMS AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2 2
Improper or Incorrect Procedure or Method 1 1
Device-Device Incompatibility 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Burning Sensation 2 2
Skin Inflammation/ Irritation 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Philips North America II Feb-01-2024
2 Philips North America III Jan-25-2024
3 Philips North America II Jan-11-2024
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