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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
INDICA LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LEICA BIOSYSTEMS IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS ELECTRONICS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 2
PROSCIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SECTRA AB
  SUBSTANTIALLY EQUIVALENT 1
VENTANA MEDICAL SYSTEMS, INC.
  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
Application Program Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Display or Visual Feedback Problem 1 1

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

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