IBreastExam
System, Documentation, Breast Lesion
UE LifeSciences Inc.
The following data is part of a premarket notification filed by Ue Lifesciences Inc. with the FDA for Ibreastexam.
Pre-market Notification Details
| Device ID | K190575 |
| 510k Number | K190575 |
| Device Name: | IBreastExam |
| Classification | System, Documentation, Breast Lesion |
| Applicant | UE LifeSciences Inc. 3401 Market St, Suite 200 Philadelphia, PA 19104 |
| Contact | Mihir Shah |
| Correspondent | Mihir Shah UE LifeSciences Inc. 3401 Market St, Suite 200 Philadelphia, PA 19104 |
| Product Code | NKA |
| CFR Regulation Number | 884.2990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-06 |
| Decision Date | 2019-07-16 |
Trademark Results [IBreastExam]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IBREASTEXAM 97259724 not registered Live/Pending |
UE LIFESCIENCES INC. 2022-02-09 |
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