← FDA Medical Device Classifications
System, Documentation, Breast Lesion
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
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown