• 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 show TPLC since Back to Search Results
Device couch, radiation therapy, powered
Regulation Description Powered radiation therapy patient support assembly.
Product CodeJAI
Regulation Number 892.5770
Device Class 2


Premarket Reviews
ManufacturerDecision
CHINAN BIOMEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
FORTE AUTOMATION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LEONI CIA CABLE SYSTEM
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 3 3
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 4 4
Application Program Problem 3 3
Computer Software Problem 3 3
Device Stops Intermittently 1 1
Use of Device Problem 1 1
Malposition of Device 1 1
Alarm Not Visible 1 1
Output Problem 1 1
Programming Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 3 3
No Known Impact Or Consequence To Patient 1 1
Cancer 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Elekta, Inc. II Jul-24-2018
2 Forte Automation Systems Inc II Jul-25-2018
3 Med Tec Inc II Feb-21-2018
4 Med Tec Inc II Jun-15-2016
-
-