• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device system, radiation therapy, radionuclide
Regulation Description Radionuclide radiation therapy system.
Product CodeIWB
Regulation Number 892.5750
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCURAY, INC.
  SUBSTANTIALLY EQUIVALENT 2
Elekta Instrument AB
  SUBSTANTIALLY EQUIVALENT 11
MDS NORDION
  SUBSTANTIALLY EQUIVALENT 2
MICK RADIO-NUCLEAR INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Computer software issue 3
Device maintenance issue 1
Therapy delivered to incorrect body area 1
Device operates differently than expected 1
Total Device Problems 6

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 0 0 0 10 3 0 0 1 1 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Elekta, Inc. II Apr-22-2016
2 Elekta, Inc. II Jun-05-2015
3 Elekta, Inc. II Oct-30-2014
4 Elekta, Inc. II Nov-30-2011
5 Elekta, Inc. II Nov-30-2011
6 Elekta, Inc. II Feb-14-2011
7 Elekta, Inc. II Oct-28-2010
8 Elekta, Inc. II May-14-2010
9 Elekta, Inc. II Apr-29-2010
10 Elekta, Inc. II Apr-27-2010
11 Elekta, Inc. II Apr-22-2010
12 Elekta, Inc. II Apr-13-2010
13 Elekta, Inc. II Apr-05-2010
14 Elekta, Inc. II Apr-05-2010
15 Elekta, Inc. II Apr-05-2010
16 Elekta, Inc. II Mar-17-2010

-
-