Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device system, imaging, optical coherence tomography (oct)
Regulation Description Ultrasonic pulsed echo imaging system.
Definition This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
Product CodeNQQ
Regulation Number 892.1560
Device Class 2


Premarket Reviews
ManufacturerDecision
LIGHTLAB IMAGING,INC.
  SUBSTANTIALLY EQUIVALENT 2

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 1 0 0
Class III 0 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Imalux Corporation III Feb-01-2012
2 Optovue Inc. II Feb-01-2011

-
-