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) | 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 microscope, automated, image analysis, operator intervention
Definition Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention.
Product CodeNOT
Regulation Number 864.1860
Device Class 2


Premarket Reviews
ManufacturerDecision
APERIO TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
BIOIMAGENE, INC.
  SUBSTANTIALLY EQUIVALENT 1
LEICA BIOSYSTEMS IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
VENTANA MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 1 1
Misfocusing 1 1
Incorrect Software Programming Calculations 1 1
Explosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Misdiagnosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Leica Biosystems Imaging, Inc. II Oct-04-2019
2 Leica Biosystems Imaging, Inc. II Mar-07-2014
-
-