510(k) K142926
K142926 is an FDA 510(k) premarket notification submitted by Ue Lifesciences, Inc. for the device "iBreastExam". The FDA issued a decision of Substantially Equivalent on Apr 23, 2015. The device falls under product code NKA (System, Documentation, Breast Lesion), a Class II device regulated under 21 CFR 884.2990. Ue Lifesciences, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 23, 2015
- Date Received
- Oct 8, 2014
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Documentation, Breast Lesion
- Device Class
- Class II
- Regulation Number
- 884.2990
- Review Panel
- OB
- Submission Type
- 510(k)
A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam.