510(k) K181672
K181672 is an FDA 510(k) premarket notification submitted by Sure, Inc. for the device "SureTouch Mobile Pressure Mapping System". The FDA issued a decision of Substantially Equivalent on Jun 28, 2019. The device falls under product code NKA (System, Documentation, Breast Lesion), a Class II device regulated under 21 CFR 884.2990.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 28, 2019
- Date Received
- Jun 25, 2018
- Clearance Type
- Traditional
- 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.