TPLC - Total Product Life Cycle

• 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 Code: PGY
• Regulation Number: 892.2050
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
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
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