TPLC - Total Product Life Cycle

• Device: camera, scintillation (gamma)
• Product Code: IYX
• Regulation Number: 892.1100
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
DIGIRAD CORP.
	SUBSTANTIALLY EQUIVALENT	2
DILON TECHNOLOGIES LLC
	SUBSTANTIALLY EQUIVALENT	1
DILON TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
GAMMA MEDICA-IDEAS INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
	SUBSTANTIALLY EQUIVALENT	1
GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION-
	SUBSTANTIALLY EQUIVALENT	2
GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A
	SUBSTANTIALLY EQUIVALENT	2
HERMES MEDICAL SOLUTIONS AB
	SUBSTANTIALLY EQUIVALENT	1
HYBRIDYNE IMAGING TECHNOLOGIES, INC
	SUBSTANTIALLY EQUIVALENT	1
RADIOPHARMACEUTICAL IMAGING AND DOSIMETRY, LLC
	SUBSTANTIALLY EQUIVALENT	1
SCANDIA CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VERSANT MEDICAL PHYSICS AND RADIATION SAFETY
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	3	3
2015	4	4
2016	2	2
2018	1	1
2022	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Use of Device Problem	4	4
Mechanical Problem	3	3
Device Operates Differently Than Expected	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Device Handling Problem	1	1
Noise, Audible	1	1
Device Fell	1	1
Device Tipped Over	1	1
Loss of Data	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	2	2
Fracture, Arm	2	2
Bone Fracture(s)	2	2
No Information	2	2
Fall	1	1
Laceration(s)	1	1
Suture Abrasion	1	1
Skin Tears	1	1
No Known Impact Or Consequence To Patient	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Siemens Medical Solutions USA, Inc.	II	Sep-08-2016