# System, Documentation, Breast Lesion
> **Product code: NKA** · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 884.2990
## Classification
- **FDA Product Code:** NKA
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 884.2990
- **Review panel:** OB
- **Medical specialty:** Obstetrics/Gynecology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam.

## Market data
- **Cleared 510(k) submissions:** 4
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NKA)
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