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TPLC
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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
Adverse Event Without Identified Device or Use Problem
2
2
Device Operates Differently Than Expected
2
2
Device Fell
1
1
Loss of Data
1
1
Device Tipped Over
1
1
Device Handling Problem
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Fracture, Arm
2
2
No Information
2
2
Bone Fracture(s)
2
2
No Consequences Or Impact To Patient
2
2
Suture Abrasion
1
1
No Known Impact Or Consequence To Patient
1
1
Fall
1
1
Laceration(s)
1
1
Skin Tears
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Siemens Medical Solutions USA, Inc.
II
Sep-08-2016
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