510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PSYClass II

Whole Slide Imaging System

21 CFR 864.3700 / Pathology
FDA source (opens on fda.gov)

PSY is the FDA product code for Whole Slide Imaging System, a class II device type, regulated under 21 CFR 864.3700. FDA's definition for this code reads: "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...". As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
PSY
Device name
Whole Slide Imaging System
FDA 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).
Regulation
21 CFR 864.3700
Device class
Class II
Review panel
Pathology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
23
Ingested recalls
2

Clearances, product code PSY

By decision year
23 clearances under product code PSY with a decision year between 2017 and 2026, 2024 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code PSY by decision year
YearClearances
20172
20192
20212
20221
20231
20249
20252
20264

Applicants with the most clearances

Product code PSY
Applicants holding the most 510(k) clearances under product code PSY
ApplicantClearances
Philips Medical Systems Nederland B.V.7
Hamamatsu Photonics K.K.4
Leica Biosystems Imaging, Inc.3
Ventana Medical Systems Inc2
Barco N.V.1
Indica Labs LLC1
Philips Electronics Nederland B.V.1
Proscia, Inc.1
Sectra AB1
Shandon Diagnostics Limited1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order