ARTERA

FDA Device Registration & Listing · Los Altos, CA, US · Registration 3029787717

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
3029787717
FEI Number
3029787717
Entity Name
ARTERA
City/State/Country
Los Altos, CA, US
Establishment Address
108 1st St, Los Altos, CA 94022, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
Artera (Owner Number: 10093385)
Owner / Operator Contact Address
108 1st Street, Los Altos, CA 94022, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ArteraAI Prostate

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
SFH Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis Pathology Class 2 864.3755 2025-08-14
QPN Software Algorithm Device To Assist Users In Digital Pathology Pathology Class 2 864.3750 2025-05-08

Official Correspondent

Candice Bautista

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Artera
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 3029787717. Last updated year: 2026. Please use registration number 3029787717 when referencing this establishment in official correspondence.
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