Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart C — Obstetrical and Gynecological Monitoring Devices](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices) → [21 CFR 884.2990](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/884.2990) → NKA — System, Documentation, Breast Lesion

# NKA · System, Documentation, Breast Lesion

_Obstetrics/Gynecology · 21 CFR 884.2990 · Class 2_

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

## Overview

- **Product Code:** NKA
- **Device Name:** System, Documentation, Breast Lesion
- **Regulation:** [21 CFR 884.2990](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/884.2990)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## 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.

## Classification Rationale

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.

## 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.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K190575](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/NKA/K190575.md) | iBreastExam | Ue Lifesciences, Inc. | Jul 16, 2019 | SESE |
| [K181672](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/NKA/K181672.md) | SureTouch Mobile Pressure Mapping System | Sure, Inc. | Jun 28, 2019 | SESE |
| [K142926](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/NKA/K142926.md) | iBreastExam | Ue Lifesciences, Inc. | Apr 23, 2015 | SESE |
| [DEN020001](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/NKA/DEN020001.md) | BREASTVIEW VISUAL MAPPING SYSTEM | Assurance Medical | Jan 31, 2003 | DENG |

## Top Applicants

- Ue Lifesciences, Inc. — 2 clearances
- Assurance Medical — 1 clearance
- Sure, Inc. — 1 clearance

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

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