TPLC - Total Product Life Cycle

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Device	solid state x-ray imager (flat panel/digital imager)
Regulation Description	Stationary x-ray system.
Product Code	MQB
Regulation Number	892.1680
Device Class	2

Premarket Reviews
Manufacturer	Decision
A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
AGFA N.V.
	SUBSTANTIALLY EQUIVALENT	2
ALLENGERS MEDICAL SYSTEMS LIMITED
	SUBSTANTIALLY EQUIVALENT	2
ASPEN IMAGING HEALTHCARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
ASTEL, INC.
	SUBSTANTIALLY EQUIVALENT	1
CANON, INC.
	SUBSTANTIALLY EQUIVALENT	11
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CARERAY DIGITAL MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
CARESTREAM HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	2
DRTECH CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
FIRST SOURCE, INC.
	SUBSTANTIALLY EQUIVALENT	1
H&ABYZ CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
INNOCARE OPTOELECTRONICS CORP.
	SUBSTANTIALLY EQUIVALENT	4
IRAY IMAGING TECHNOLOGY (HAINING) LIMITED
	SUBSTANTIALLY EQUIVALENT	2
IRAY TECHNOLOGY TAICANG , LTD.
	SUBSTANTIALLY EQUIVALENT	9
JPI HEALTHCARE CO, LTD.
	SUBSTANTIALLY EQUIVALENT	1
KONICA MINOLTA HEALTHCARE AMERICAS, INC.
	SUBSTANTIALLY EQUIVALENT	2
KONICA MINOLTA, INC.
	SUBSTANTIALLY EQUIVALENT	5
LG ELECTRONICS.INC
	SUBSTANTIALLY EQUIVALENT	6
MEDICATECH USA
	SUBSTANTIALLY EQUIVALENT	1
PIXXGEN CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
PZMEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
RADISEN CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
RADMEDIX, LLC
	SUBSTANTIALLY EQUIVALENT	2
RAY IMAGING TECHNOLOGY (HAINING) LIMITED
	SUBSTANTIALLY EQUIVALENT	1
RAYENCE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	6
VIEWORKS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Fell	217	217
Device Handling Problem	214	214
Detachment of Device or Device Component	65	65
Poor Quality Image	14	14
Mechanical Jam	8	8
Insufficient Device Problem Information	6	6
Fire	5	5
Unintended System Motion	3	3
Electrical /Electronic Property Problem	3	3
Smoking	3	3
Use of Device Problem	3	3
Fitting Problem	2	2
Misassembled During Installation	2	2
Mechanical Problem	2	2
Sparking	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Use of Incorrect Control/Treatment Settings	1	1
Power Problem	1	1
Material Integrity Problem	1	1
Radiation Output Problem	1	1
Patient-Device Incompatibility	1	1
Device Slipped	1	1
Image Display Error/Artifact	1	1
Difficult or Delayed Separation	1	1
Communication or Transmission Problem	1	1
Circuit Failure	1	1
Difficult to Advance	1	1
Unintended Movement	1	1
Radiation Underexposure	1	1
No Display/Image	1	1
Retraction Problem	1	1
Failure to Align	1	1
Display or Visual Feedback Problem	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	305	305
No Patient Involvement	4	4
Unspecified Musculoskeletal problem	4	4
Bone Fracture(s)	3	3
Laceration(s)	3	3
Damage to Ligament(s)	2	2
Muscle/Tendon Damage	2	2
Insufficient Information	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Skin Tears	2	2
Unintended Radiation Exposure	1	1
Vomiting	1	1
Hair Loss	1	1
Radiation Sickness Syndrome	1	1
Nausea	1	1
Joint Impingement	1	1
Hip Fracture	1	1
Easy Bruising	1	1
Eye Injury	1	1
Pain	1	1
Unspecified Eye / Vision Problem	1	1
Dyspnea	1	1
Joint Dislocation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Canon Medical System, USA, INC.	II	Mar-17-2021
2	Canon Medical System, USA, INC.	II	Mar-09-2021
3	LIEBEL-FLARSHEIM COMPANY LLC	II	Jul-02-2021
4	Philips Healthcare	II	Nov-24-2021
5	Philips Medical Systems DMC GmbH	II	Nov-07-2025
6	Philips North America Llc	II	Jun-05-2026
7	Philips North America Llc	II	Jun-30-2023