← Product Code [NKA](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/NKA) · DEN020001

# BREASTVIEW VISUAL MAPPING SYSTEM (DEN020001)

_Assurance Medical · NKA · Jan 31, 2003 · Obstetrics/Gynecology · DENG_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/NKA/DEN020001

## Device Facts

- **Applicant:** Assurance Medical
- **Product Code:** [NKA](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/NKA.md)
- **Decision Date:** Jan 31, 2003
- **Decision:** DENG
- **Submission Type:** Post-NSE
- **Regulation:** 21 CFR 884.2990
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

A breast lesion documentation system is a device for use in producing a surface map of the breast as an aid to document palpable breast lesions identified during a clinical breast examination.

## Special Controls

*Classification.* Class II (special controls). The device, when it is a breast examination recording sheet, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Breast Lesion Documentation System.” See § 884.1(e) for the availability of this guidance document.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/NKA/DEN020001](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/NKA/DEN020001)

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