NKA
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- System, Documentation, Breast Lesion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2990
- Medical specialty
- Obstetrics/Gynecology
- FDA definition
- A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| iBreastExam (K190575) | Ue Lifesciences, Inc. | 2019-07-16 |
| SureTouch Mobile Pressure Mapping System (K181672) | Sure, Inc. | 2019-06-28 |
| iBreastExam (K142926) | Ue Lifesciences, Inc. | 2015-04-23 |
| BREASTVIEW VISUAL MAPPING SYSTEM (DEN020001) | Assurance Medical | 2003-01-31 |
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