System, Documentation, Breast Lesion
The Breast Lesion Documentation System is a device used for recording and documenting palpable breast lesions detected during a clinical breast examination, providing structured documentation to support clinical decision-making and follow-up. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NKA and regulation 21 CFR 884.2990 in the Obstetrics and Gynecology specialty. The device carries no implant or life-sustaining flags.
Basic Information
- Product Code
- NKA
- Device Class
- FDA class 2
- Regulation Number
- 884.2990
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
Definition
A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K190575 | iBreastExam | Jul 16, 2019 | Substantially Equivalent | Ue Lifesciences, Inc. |
| K181672 | SureTouch Mobile Pressure Mapping System | Jun 28, 2019 | Substantially Equivalent | Sure, Inc. |
| K142926 | iBreastExam | Apr 23, 2015 | Substantially Equivalent | Ue Lifesciences, Inc. |
| DEN020001 | BREASTVIEW VISUAL MAPPING SYSTEM | Jan 31, 2003 | Unknown | Assurance Medical |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.