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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
  SUBSTANTIALLY EQUIVALENT 4
CIANNA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CIANNA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SE - WITH LIMITATIONS 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 3
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SE - WITH LIMITATIONS 2
MICK RADIO-NUCLEAR INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 19
NUCLETRON
  SUBSTANTIALLY EQUIVALENT 5
PROXIMA
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 3
SENORX, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SE - WITH LIMITATIONS 4
STANDARD IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 3
VARIAN
  SUBSTANTIALLY EQUIVALENT 28

Device Problems
No Known Device Problem 19
Leak 6
Device operates differently than expected 4
Tears, rips, holes in device, device material 4
Use of Device Issue 2
Improper or incorrect procedure or method 2
Material rupture 2
Computer software issue 2
Decoupling 1
Explanted 1
Instruction for use issue 1
Normal 1
Balloon rupture 1
Balloon leak(s) 1
Burst 1
Improper device output 1
Material Distortion 1
Defective component 1
Device Issue 1
Detachment of device or device component 1
Device markings issue 1
Total Device Problems 54

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 1 1 1 0 9 2 3 0 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Medical Solutions USA, Inc II Jun-01-2009
2 Varian Medical Systems II Jan-11-2007
3 Varian Medical Systems Inc II Jun-26-2015
4 Varian Medical Systems Inc II Jun-23-2015
5 Varian Medical Systems, Inc. II Oct-24-2013
6 Varian Medical Systems, Inc. II May-15-2013
7 Varian Medical Systems, Inc. II Jan-31-2013
8 Varian Medical Systems, Inc. II Dec-20-2012
9 Varian Medical Systems, Inc. II Mar-12-2012
10 Varian Medical Systems, Inc. II Dec-01-2011
11 Varian Medical Systems, Inc. II Dec-01-2011
12 Varian Medical Systems, Inc. II Nov-30-2011
13 Varian Medical Systems, Inc. II Nov-23-2011
14 Varian Medical Systems, Inc. II Sep-16-2008
15 Varian Medical Systems, Inc. Oncology Systems II Dec-01-2011
16 Varian Medical Systems, Inc. Oncology Systems II Aug-22-2011
17 Varian Medical Systems, Inc. Oncology Systems II Aug-12-2011
18 Varian Medical Systems, Inc. Oncology Systems II Aug-11-2011
19 Varian Medical Systems, Inc. Oncology Systems II Aug-10-2011

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