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K Number
DEN020001
Device Name
BREASTVIEW VISUAL MAPPING SYSTEM
Manufacturer
ASSURANCE MEDICAL
Date Cleared
2003-01-31

(248 days)

Product Code
NKA
Regulation Number
884.2990
Type
Post-NSE
Panel
OB
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 884.2990 Breast lesion documentation system.

(a)
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.(b)
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.