FDA.reportPublic FDA data

PROSCIA, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30257749733025774973PROSCIA, INC.1N2026-01-011700 Market St Fl 24 Philadelphia PA US 19103

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860006054519Concentriq AP-Dx - Concentriq AP-Dx is a web-based, software-only device that is intended to aid pathology professionals in viewing, interpretation and management of digital whole slide images (WSI) of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue obtained from Hamamatsu NanoZoomer S360MD Slide scanner. It aids the pathologist in the review, interpretation, and management of pathology slide digital images used to generate a primary diagnosis.+1 215 608 5411support@proscia.com
00860006054557Concentriq AP-Dx-US - Concentriq® AP-Dx is a software only device intended for viewing and management of digital imagesof scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It isan aid to the pathologist to review, interpret and manage these digital slide images for the purpose ofprimary diagnosis. Concentriq AP-Dx is not intended for use with frozen sections, cytology, or non-FFPEhematopathology specimens.+1 (215) 608-5411info@proscia.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3192591435878143K230839Concentriq DxPSY2024-02-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PSY12024-02-08

PMN#

GUDID#

Concentriq AP-Dx - Concentriq AP-Dx is a diagnostic software device for viewing and managing digital pathology slides from FFPE tissue. It aids pathologists in reviewing and interpreting digital slide images for primary diagnosis, specifically with Hamamatsu NanoZoomer S360MD scanner and JVC monitor. The software requires qualified pathologists to ensure image quality and interpretation validity. Not intended for frozen sections, cytology, or non-FFPE hematopathology specimens.

Proscia Inc.

2025-05-08

Concentriq AP-Dx - Concentriq AP-Dx is a web-based, software-only device that is intended to aid pathology professionals in viewing, interpretation and management of digital whole slide images (WSI) of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue obtained from Hamamatsu NanoZoomer S360MD Slide scanner. It aids the pathologist in the review, interpretation, and management of pathology slide digital images used to generate a primary diagnosis.

Proscia Inc.

2024-08-26