TPLC - Total Product Life Cycle

show TPLC since

Device	system, image management, ophthalmic
Product Code	NFJ
Regulation Number	892.2050
Device Class	2

Premarket Reviews
Manufacturer	Decision
CANON INC.
	SUBSTANTIALLY EQUIVALENT	1
CANON INC. -MEDICAL EQUIPMENT GROUP
	SUBSTANTIALLY EQUIVALENT	1
CARL ZEISS MEDITEC AG
	SUBSTANTIALLY EQUIVALENT	2
CARL ZEISS MEDITEC, INC
	SUBSTANTIALLY EQUIVALENT	1
HUVITZ CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INTEGRATED OPHTHALMIC SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
KONAN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
KOWA CO. LTD. CHOFU
	SUBSTANTIALLY EQUIVALENT	1
MERIT CRO, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEUROVISION IMAGING, LLC
	SUBSTANTIALLY EQUIVALENT	1
NIDEK CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
OPHTHALMIC LABS, INC.
	SUBSTANTIALLY EQUIVALENT	1
RETINAI MEDICAL AG
	SUBSTANTIALLY EQUIVALENT	1
TOPCON HEALTHCARE SOLUTIONS EMEA OY
	SUBSTANTIALLY EQUIVALENT	1
TOPCON HEALTHCARE SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
TOPCON MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
VISIONQUEST BIOMEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
WELCH ALLYN, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Computer Software Problem	2	2
Use of Incorrect Control/Treatment Settings	1	1
Output Problem	1	1
Data Problem	1	1
Device Handling Problem	1	1
Program or Algorithm Execution Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Blurred Vision	1	1
No Consequences Or Impact To Patient	1	1
Capsular Bag Tear	1	1
No Known Impact Or Consequence To Patient	1	1
Unspecified Eye / Vision Problem	1	1
Insufficient Information	1	1