FDA.reportPublic FDA data

iReveal Breast Density Assessment

Primary DI
00858012005205
Brand
iReveal Breast Density Assessment
Company
Icad, Inc.
Model
V2.1
Catalog number
D70124, D70141 and D70126
Device description
PowerLook Density Assessment is a software application intended for use with digital mammographysystems. PowerLook Density Assessment calculates breast density as a ratio of fibroglandular tissue andtotal breast area estimates. PowerLook Density Assessment provides these numerical values for eachbreast as well as a density category to aid radiologists in the assessment of breast tissuecomposition. PowerLook Density Assessment produces adjunctive information. It is not an interpretive ordiagnostic aid.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132742000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132742000M-VU BREAST DENSITYVucomp, Inc.2013-12-03LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858012005205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858012005205008580120052058580120052050858012005205

GMDN Terms#

Term, Definition table
TermDefinition
Basic diagnostic x-ray system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose x-ray imaging system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routine packages must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-280-2239support@icadmed.com

Regulatory Flags#

DUNS number
108870254
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850008977541ProFound Detection4.02026-03-23
00850008977282TESTING2.02024-06-10
00850008977053TESTING1.02024-06-10
00850008977251PowerLook Density Assessment V4.04.02024-06-10
00850008977268ProFound AI 3.13.12024-06-10
00850008977275ProFound AI 3.13.12024-06-10
00850008977299PowerLook PRO+ 4GPU Tower Platform, OUSDSC018-082024-06-10
00850008977305PowerLook 10.1.1D4D02312024-06-10
00850008977312PowerLook MammoAI Container - SectraDSC026-012024-06-10
00850008977329PowerLook MammoAI Container - ArterysDSC028-012024-06-10
00850008977343PowerLook 11112024-06-10
00850008977350PowerLook MammoAI Container - GE1.02024-06-07
00850008977367PowerLook 11.111.12024-06-07
00850008977374PowerLook PRO+, OUSDSC030-01, DSC030-02, DSC030-032024-06-07
00850008977381PowerLook PRO+ 2GPU Tower Platform, USDSC029-01, DSC029-02, DSC029-032024-06-07
00850008977398PowerLook PRO+ Rack-Mount, OUSDSC034-01, DSC034-02, DSC034-032024-06-07
00850008977404PowerLook PRO+ Rack-Mount, USDSC033-01, DSC033-02, DSC033-032024-06-07
00850008977411PowerLook PRO+ 4GPU Tower Platform, USDSC031-01, DSC031-02, DSC031-032024-06-07
00850008977534PowerLook AI Mammo Container 1.0.0 BlackfordDSC036-012024-06-07
00850008977428PowerLook PRO+ 4GPU Tower Platform, OUSDSC032-01, DSC032-02, DSC032-032023-07-14

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