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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
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
BARCO N.V.
  SUBSTANTIALLY EQUIVALENT 1
BARCO NV
  SUBSTANTIALLY EQUIVALENT 6
BENQ CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EIZO CORPORATION
  SUBSTANTIALLY EQUIVALENT 12
JVC KENWOOD CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
JVCKENWOOD CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
LG ELECTRONICS INC.
  SUBSTANTIALLY EQUIVALENT 11
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 6
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 8
QINGDAO HISENSE MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
QINGDAO HISENSE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
QUANTUM-SPECTRA LLC
  SUBSTANTIALLY EQUIVALENT 1
QUBYX SOFTWARE TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BEACON DISPLAY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
  1.  K172815  2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)
  2.  K182291  6MP Color LCD Monitor (C61W+)
  3.  K200864  5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochro ...
  4.  K201211  3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochro ...
  5.  K201599  2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G2 ...
  6.  K202374  4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85 ...
  7.  K233897  5MP Color LCD Monitors/ 5MP Monochrome LCD Monitor ...
SHENZHEN BEACON DISPLAY TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
THE LINDEN GROUP CORP
  SUBSTANTIALLY EQUIVALENT 1
WIDE CORPORATION
  SUBSTANTIALLY EQUIVALENT 8

MDR Year MDR Reports MDR Events
2017 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment Of Device Component 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 1 1

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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