PATHAI

FDA Device Registration & Listing · Boston, MA, US · Registration 3020687180

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3020687180
FEI Number
3020687180
Entity Name
PATHAI
City/State/Country
Boston, MA, US
Establishment Address
1325 Boylston Street Suite 10000, Boston, MA 02215, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
PathAI (Owner Number: 10085829)
Owner / Operator Contact Address
1325 Boylston Street Suite 10000, Boston, MA 02215, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K243391
PMA Number
N/A

All Registered Proprietary Names

AISight Dx

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QKQ Digital Pathology Image Viewing And Management Software Pathology Class 2 864.3700 2025-07-03

Official Correspondent

Carrene Plummer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PathAI
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020687180. Last updated year: 2026. Please use registration number 3020687180 when referencing this establishment in official correspondence.
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