SureTouch Mobile Pressure Mapping System
by Sure Inc.
510(k) K181672
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK181672 | Date28 Jun 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NKA
- FDA applicant
- Sure, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.2990
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The SureTouch Mobile Pressure Mapping System is a pressure mapping device designed to generate a surface pressure map of the breast. It aids in documenting palpable breast lesions identified during a clinical breast examination, providing visual data to support diagnostic assessment. This system is classified as a Class II medical device under FDA regulations, intended for use in obstetrics and gynecology settings. Its primary function is to assist qualified healthcare professionals in evaluating breast tissue under controlled pressure conditions.
The device is supplied as a reusable system and is intended for use in clinical environments only, not for home use. It operates under FDA 510(k) clearance (K181672) and is regulated under the Breast Lesion Documentation category (regulation number 884.2990). The system includes multiple FEI numbers (3010914393, 3020798169, 3013951855) for traceability and compliance. No specific sterility or MRI safety information is provided in the regulatory data.
Other devices from Sure Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the SureTouch Mobile Pressure Mapping System used for?
The SureTouch Mobile Pressure Mapping System generates a surface pressure map of the breast to document palpable lesions found during clinical breast examinations. This visual data helps healthcare professionals assess breast tissue under controlled pressure, supporting diagnostic decisions in obstetrics and gynecology settings.
Is the SureTouch Mobile Pressure Mapping System reusable or single-use?
The system is designed for reusable clinical use only and is not intended for home or patient self-use. Its durable construction allows repeated use in professional healthcare environments, ensuring consistent performance for diagnostic evaluations.
What regulatory approval does the SureTouch Mobile Pressure Mapping System hold?
The device holds FDA 510(k) clearance under the classification of Breast Lesion Documentation (regulation number 884.2990). It was reviewed by the Obstetrics/Gynecology Advisory Committee and deemed substantially equivalent to a predicate device, ensuring compliance with U.S. medical device regulations.
How is the SureTouch Mobile Pressure Mapping System supplied, and what traceability features does it include?
The system is supplied as a reusable clinical tool, intended exclusively for professional use. It includes multiple FEI numbers (3010914393, 3020798169, 3013951855) for traceability and compliance tracking, ensuring proper documentation and regulatory adherence in healthcare settings.
Does the SureTouch Mobile Pressure Mapping System require any special handling or storage?
While specific sterility or MRI safety information is not provided in the regulatory data, the device is intended for clinical environments only. Proper cleaning and maintenance protocols should follow manufacturer guidelines to preserve functionality and ensure accurate pressure mapping results for diagnostic purposes.