Bexa Pressure Mapping System

Primary DI
00860000501729
Brand
Bexa Pressure Mapping System
Company
SURE INC.
Model
1885
Device description
Breast lesion documentation system
Published
2021-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKASystem, Documentation, Breast Lesion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKASystem, Documentation, Breast LesionObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181672000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181672000SureTouch Mobile Pressure Mapping SystemSure, Inc.2019-06-28NKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860000501729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860000501729008600005017298600005017290860000501729

GMDN Terms#

Term, Definition table
TermDefinition
Electronic clinical breast examination systemA portable assembly of devices designed to electronically measure, map, document and store information about breast lesions/masses with regard to shape, size, location, consistency/relative hardness during a clinical breast examination (CBE). It is typically used by physicians/clinical practitioners that perform CBE during breast cancer screening and evaluation of suspected breast masses. It typically consists of a hand-held applicator (tactile receptor containing pressure transducers), a portable computer, application software, and a calibrator. Scanning is performed over the entire breast or an area of interest and is typically displayed as a colour map differentiating the tissues.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(833) 787-3462info@mybexa.com

Regulatory Flags#

DUNS number
116944848
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860000501712SureTouch Mobile Pressure Mapping System18852021-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493418179RIVA Posterior Fixation SystemXENIX MEDICAL LLCNKA2026-03-10
00840493409375RIVA Posterior Fixation SystemXENIX MEDICAL LLCNKA2026-01-30
00860000501712SureTouch Mobile Pressure Mapping SystemSURE INC.NKA2021-10-28