Data / Medical devices / United States / Ue Lifesciences Inc.
Ue Lifesciences Inc.: FDA-registered device maker in Philadelphia, PA, United States, 3 510(k) clearances
Ue Lifesciences Inc. is registered with the FDA (registration 3010914393) in Philadelphia, PA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 16, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010914393
- Address
- 3675 Market St Ste 200, Philadelphia, PA, United States, 19104
- Owner or operator
- UE LifeSciences Inc. (10044277)
- Roles
- Specification developer
- First device listed
- May 20, 2013
- Registered through
- 2026
- Brand names listed
- iBreastExam, iBreastExam Gen2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Documentation, Breast Lesion | NKA | 2 | Specification developer | accessdata.fda.gov |
| System, Telethermographic (Adjunctive Use) | LHQ | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 16, 2019 | K190575 | iBreastExam | NKA | Substantially Equivalent | Ue Lifesciences, Inc. | accessdata.fda.gov |
| April 23, 2015 | K142926 | iBreastExam | NKA | Substantially Equivalent | Ue Lifesciences, Inc. | accessdata.fda.gov |
| February 10, 2012 | K113259 | NOTOUCH BREASTSCAN | LHQ | Substantially Equivalent | Ue Lifesciences, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Documentation, Breast Lesion
- All makers of System, Telethermographic (Adjunctive Use)
Updated July 16, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.