TPLC - Total Product Life Cycle

• Device: system, x-ray, mammographic
• Regulation Description: Mammographic x-ray system.
• Product Code: IZH
• Regulation Number: 892.1710
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
HOLOGIC, INC
	SUBSTANTIALLY EQUIVALENT	1
IMS GIOTTO S.P.A.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	7	7
2021	9	9
2022	4	4
2023	8	8
2024	5	5
2025	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended System Motion	6	6
Adverse Event Without Identified Device or Use Problem	5	5
Imprecision	4	4
Use of Device Problem	3	3
Device Operational Issue	2	2
Poor Quality Image	2	2
Defective Device	2	2
Unexpected Shutdown	1	1
Malposition of Device	1	1
Communication or Transmission Problem	1	1
Application Program Problem	1	1
Device Fell	1	1
Failure to Obtain Sample	1	1
Flare or Flash	1	1
Mechanics Altered	1	1
Calibration Problem	1	1
Optical Problem	1	1
Product Quality Problem	1	1
Detachment of Device or Device Component	1	1
Electrical Shorting	1	1
Activation Failure	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	13	13
No Consequences Or Impact To Patient	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Insufficient Information	3	3
Skin Tears	3	3
Pain	2	2
Unspecified Infection	1	1
Radiation Exposure, Unintended	1	1
Hematoma	1	1
Perforation	1	1
Laceration(s)	1	1
Scar Tissue	1	1
Physical Entrapment	1	1
Muscle/Tendon Damage	1	1
Unspecified Tissue Injury	1	1
Hemorrhage/Bleeding	1	1
Deformity/ Disfigurement	1	1