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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, applicator, radionuclide, remote-controlled
Regulation Description Remote controlled radionuclide applicator system.
Product CodeJAQ
Regulation Number 892.5700
Device Class 2


Premarket Reviews
ManufacturerDecision
BEST MEDICAL INTERNA
  SUBSTANTIALLY EQUIVALENT 1
C4 IMAGING LLC
  SUBSTANTIALLY EQUIVALENT 1
ECKERT & ZIEGLER BEBIG GMBH
  SUBSTANTIALLY EQUIVALENT 1
ELEKTA INC
  SUBSTANTIALLY EQUIVALENT 4
GC MEDTECH, LLC
  SUBSTANTIALLY EQUIVALENT 2
MICK RADIO-NUCLEAR INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 2
MICK RADIO-NUCLEAR INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
NUCLETRON
  SUBSTANTIALLY EQUIVALENT 6
NUCLETRON BV
  SUBSTANTIALLY EQUIVALENT 2
SPENCER FILLMORE
  SUBSTANTIALLY EQUIVALENT 1
VARIAN
  SUBSTANTIALLY EQUIVALENT 16
VARIAN MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 22

Device Problems
Use of Device Problem 5
Adverse Event Without Identified Device or Use Problem 4
Manufacturing, Packaging or Shipping Problem 3
Improper or Incorrect Procedure or Method 3
Material Integrity Problem 3
Device Disinfection Or Sterilization Issue 3
Device Operates Differently Than Expected 2
Computer Software Problem 2
Insufficient Information 1
Material Separation 1
Device Component Or Accessory 1
Labelling, Instructions for Use or Training Problem 1
Off-Label Use 1
Total Device Problems 30

Recalls
Manufacturer Recall Class Date Posted
1 Varian Medical Systems Inc II Jun-26-2015
2 Varian Medical Systems Inc II Jun-23-2015

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