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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
2017 2 2
2018 4 4
2019 2 2
2020 2 2
2021 2 2
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 6 6
No Display/Image 2 2
Device Emits Odor 1 1
Smoking 1 1
Contamination /Decontamination Problem 1 1
Temperature Problem 1 1
Data Problem 1 1
Complete Loss of Power 1 1
Unexpected Shutdown 1 1
Program or Algorithm Execution Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Radiation Exposure, Unintended 6 6
No Clinical Signs, Symptoms or Conditions 3 3
No Known Impact Or Consequence To Patient 2 2
Partial thickness (Second Degree) Burn 1 1
No Code Available 1 1
Insufficient Information 1 1
Unspecified Infection 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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