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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device display, diagnostic radiology
Regulation Description Medical image management and processing system.
Definition The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.
Product CodePGY
Regulation Number 892.2050
Device Class 2


Premarket Reviews
ManufacturerDecision
ACULA TECHNOLOGY CORP
  SUBSTANTIALLY EQUIVALENT 1
ACULA TECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 1
BARCO N.V.
  SUBSTANTIALLY EQUIVALENT 1
BARCO NV
  SUBSTANTIALLY EQUIVALENT 3
EIZO CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
JVCKENWOOD CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
LG ELECTRONICS INC.
  SUBSTANTIALLY EQUIVALENT 10
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
QINGDAO HISENSE MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
QINGDAO HISENSE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
QUANTUM-SPECTRA LLC
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BEACON DISPLAY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
SHENZHEN BEACON DISPLAY TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 3
THE LINDEN GROUP CORP
  SUBSTANTIALLY EQUIVALENT 1
WIDE CORPORATION
  SUBSTANTIALLY EQUIVALENT 6

Recalls
Manufacturer Recall Class Date Posted
1 Barco N.V. II Mar-04-2021
2 Eizo Corporation II Jun-08-2020
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