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TPLC
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Device
densitometer, bone
Product Code
KGI
Regulation Number
892.1170
Device Class
2
Premarket Reviews
Manufacturer
Decision
3D-SHAPER MEDICAL S.L
SUBSTANTIALLY EQUIVALENT
1
COOPER SURGICAL
SUBSTANTIALLY EQUIVALENT
1
GE MEDICAL SYSTEMS LUNAR
SUBSTANTIALLY EQUIVALENT
1
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGN
SUBSTANTIALLY EQUIVALENT
1
1. K133664
ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE D
...
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC
SUBSTANTIALLY EQUIVALENT
1
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS,LLC
SUBSTANTIALLY EQUIVALENT
2
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA
SUBSTANTIALLY EQUIVALENT
1
HEARTLUNG CORPORATION
SUBSTANTIALLY EQUIVALENT
1
HOLOGIC, INC.
SUBSTANTIALLY EQUIVALENT
3
LONE OAK MEDICAL TECHNOLOGIES, LLC
SUBSTANTIALLY EQUIVALENT
1
MEDIMAPS GROUP SA
SUBSTANTIALLY EQUIVALENT
2
MINDWAYS SOFTWARE, INC.
SUBSTANTIALLY EQUIVALENT
1
O.N. DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
2
2
2016
1
1
2017
16
16
2018
6
6
2020
2
2
2021
1
1
2022
1
1
2023
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Displays Incorrect Message
10
10
Poor Quality Image
8
8
Device Stops Intermittently
5
5
Use of Device Problem
1
1
Defective Component
1
1
Computer Software Problem
1
1
No Display/Image
1
1
Device Maintenance Issue
1
1
Mechanical Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Mechanics Altered
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Unintended Movement
1
1
Patient Data Problem
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Not Applicable
21
21
Insufficient Information
3
3
No Known Impact Or Consequence To Patient
2
2
No Clinical Signs, Symptoms or Conditions
1
1
No Code Available
1
1
Unintended Radiation Exposure
1
1
Bone Fracture(s)
1
1
Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cooper Surgical, Inc.
II
Nov-18-2011
2
GE Healthcare, LLC
II
Apr-24-2020
3
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
II
Apr-17-2018
4
Ge Healthcare
II
Jan-27-2010
5
Hologic, Inc.
II
Aug-25-2009
6
Medimaps Group
II
Nov-05-2016
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