• 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, therapeutic, x-ray
Regulation Description X-ray radiation therapy system.
Product CodeJAD
Regulation Number 892.5900
Device Class 2


Premarket Reviews
ManufacturerDecision
Action Products Incorporated
  SUBSTANTIALLY EQUIVALENT 1
ADAC
  SUBSTANTIALLY EQUIVALENT 2
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 5
COMPUTERIZED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
iCAD Inc.
  SUBSTANTIALLY EQUIVALENT 1
NUCLETRON
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device displays error message 2
No Known Device Problem 1
Output below specifications 1
Output issue 1
Radiation Underexposure 1
No code available 1
Total Device Problems 7

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 1 0 1 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Action Products Incorporated II Sep-22-2009
2 Carl Zeiss Meditec, Inc. II Nov-20-2012
3 Carl Zeiss Meditec, Inc. II Aug-10-2011

-
-