TPLC - Total Product Life Cycle

show TPLC since

Device	x-ray, tomography, computed, dental
Regulation Description	Computed tomography x-ray system.
Definition	Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.
Product Code	OAS
Regulation Number	892.1750
Device Class	2

Premarket Reviews
Manufacturer	Decision
ALLIAGE S/A INDUSTRIAS MEDICO ODONTOLÓGICA
	SUBSTANTIALLY EQUIVALENT	2
CEFLA S.C.
	SUBSTANTIALLY EQUIVALENT	3
CHANGZHOU FINNO MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DE GOTZEN S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
DENTIUM CO., LTD (ICT BRANCH)
	SUBSTANTIALLY EQUIVALENT	3
DENTSPLY SIRONA
	SUBSTANTIALLY EQUIVALENT	1
DURR DENTAL SE
	SUBSTANTIALLY EQUIVALENT	2
FONA S.R.L
	SUBSTANTIALLY EQUIVALENT	1
FUSSEN TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GENORAY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
HDX WILL CORP.
	SUBSTANTIALLY EQUIVALENT	2
J. MORITA USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEGAGEN IMPLANT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MIDMARK CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
OSSTEM IMPLANT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
PALODEX GROUP OY
	SUBSTANTIALLY EQUIVALENT	2
PLANMECA OY
	SUBSTANTIALLY EQUIVALENT	1
PLANMED OY
	SUBSTANTIALLY EQUIVALENT	1
PREXION CORPORATION
	SUBSTANTIALLY EQUIVALENT	5
RAY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
TRIDENT S.R.L
	SUBSTANTIALLY EQUIVALENT	1
TROPHY
	SUBSTANTIALLY EQUIVALENT	1
VATECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	6
YIAN MEDICAL TECHNOLOGY (HAINING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
YOFO MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	1	1
Radiation Output Problem	1	1
Output Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Head Injury	2	2
Arrhythmia	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Anxiety	1	1
Rash	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Shaking/Tremors	1	1
Fatigue	1	1