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 whole slide imaging system
Definition The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. The system generates digital images that would otherwise be appropriate for manual visualization by conventional brightfield microscopy. The whole slide imaging system is not intended for use with slides prepared from frozen tissue, cytology, and non-FFPE hematopathology specimens (e.g., peripheral blood smear).
Product CodePSY
Regulation Number 864.3700
Device Class 2


Premarket Reviews
ManufacturerDecision
BARCO NV
  SUBSTANTIALLY EQUIVALENT 1
HAMAMATSU PHOTONICS K.K.
  SUBSTANTIALLY EQUIVALENT 2
LEICA BIOSYSTEMS IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS ELECTRONICS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 2
PROSCIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SECTRA AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Application Program Problem 1 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Hamamatsu Corporation II Aug-01-2023
-
-