Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042248140

FEI Number

3042248140

Entity Name

CLAIRITY, INC.

City/State/Country

Boston, MA, US

Establishment Address

361 Newbury St Ste 402, Boston, MA 02115, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Clairity, Inc. (Owner Number: 10094517)

Owner / Operator Contact Address

361 Newbury St, Suite 402, Boston, MA 02115, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN240047

PMA Number

N/A

All Registered Proprietary Names

Clairity Breast

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SEZ	Radiological Software Device To Predict Future Breast Cancer Risk	Radiology	Class 2	892.8500	2025-12-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Clairity, Inc.

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 3042248140. Last updated year: 2026. Please use registration number 3042248140 when referencing this establishment in official correspondence.