UE LIFESCIENCES INC.

FDA Device Registration & Listing · Philadelphia, PA, US · Registration 3010914393

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
3010914393
FEI Number
3010914393
Entity Name
UE LIFESCIENCES INC.
City/State/Country
Philadelphia, PA, US
Establishment Address
3675 Market St Ste 200, Philadelphia, PA 19104, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
UE LifeSciences Inc. (Owner Number: 10044277)
Owner / Operator Contact Address
3401 Market St, Suite 200, Philadelphia, PA 19104, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K190575
PMA Number
N/A

All Registered Proprietary Names

iBreastExam iBreastExam Gen2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NKA System, Documentation, Breast Lesion Obstetrics/Gynecology Class 2 884.2990 2016-01-22
LHQ System, Telethermographic (Adjunctive Use) Obstetrics/Gynecology Class 1 884.2980 2013-05-20
NKA System, Documentation, Breast Lesion Obstetrics/Gynecology Class 2 884.2990 2019-08-14

Official Correspondent

Mihir Shah

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013951855 UE LifeSciences (India) Pvt Ltd Mumbai Maharashtra, IN

Similar Registrations

Registration Number Establishment Name Location
3013951855 UE LifeSciences (India) Pvt Ltd Mumbai Maharashtra, IN
3020798169 Bexa, Inc. Pleasantville, NY, US
3017970306 THERMIDAS OY TAMPERE Pirkanmaa, FI
3041915306 USA Therm Inc. Hollywood, FL, US
3007420760 INFRARED CAMERAS INC. Beaumont, TX, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010914393. Last updated year: 2026. Please use registration number 3010914393 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.