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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device system, digital image communications, radiological
Definition A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions.
Product CodeLMD
Regulation Number 892.2020
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 2 2
2021 2 2
2022 6 6
2023 7 7
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Unexpected Shutdown 4 4
No Display/Image 3 3
Device Operational Issue 3 3
Complete Loss of Power 3 3
Fire 2 2
Unintended Application Program Shut Down 2 2
Adverse Event Without Identified Device or Use Problem 2 2
No Apparent Adverse Event 2 2
Erratic or Intermittent Display 2 2
Smoking 1 1
Contamination /Decontamination Problem 1 1
Program or Algorithm Execution Problem 1 1
Use of Device Problem 1 1
Overheating of Device 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
Radiation Exposure, Unintended 3 3
Insufficient Information 3 3
Unspecified Infection 1 1
Bowel Perforation 1 1
Partial thickness (Second Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Skytron, Div. The KMW Group, Inc II Oct-15-2020
2 Skytron, Div. The KMW Group, Inc II Oct-08-2020
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