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 mammography systems. PowerLook Density Assessment calculates breast density as a ratio of fibroglandular tissue and total breast area estimates. PowerLook Density Assessment provides these numerical values for each breast as well as a density category to aid radiologists in the assessment of breast tissue composition. PowerLook Density Assessment produces adjunctive information. It is not an interpretive or diagnostic 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
OTC
false
Sterile
false
Single use
false

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 x-ray clinical assessment support softwareA software program intended to display, analyse/process, and possibly acquire static two-dimensional (2-D) x-ray images of bones and/or the abdominothoracic region, acquired by a basic diagnostic x-ray system, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage, image quality assessment) of a trauma or condition (typically orthopaedic, cardiac or pulmonary). It is not dedicated to treatment planning and does not incorporate adaptive/dynamic machine learning (ML) models.

Contacts#

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

Regulatory Flags#

DUNS number
108870254
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850008977176ProFound AI V3.03.02021-05-17
00850008977183PowerLook AMP with Density Assessment GE USDSC012-022021-05-17
00850008977190PowerLook AMP with Density Assessment GE OUSDSC012-032021-05-17
00858012005090PowerLook AMP SLD GE OUSDSC010-01-EU2021-05-17
00858012005106PowerLook AMP SLD GE OUS DirectDSC010-12-EU2021-05-17
00858012005113PowerLook AMP SLD Siemens OUSDSC010-03-EU2021-05-17
00858012005120PowerLook AMP SLD Fuji OUSDSC010-04-EU2021-05-17
00858012005137PowerLook AMP SLD Hologic OUSDSC010-05-EU2021-05-17
00858012005144PowerLook AMP SLD GiottoDSC010-062021-05-17
00858012005151PowerLook AMP SLD Philips OUSDSC010-07-EU2021-05-17
00858012005168PowerLook AMP SLD PlanmedDSC010-082021-05-17
00858012005175PowerLook AMP SLD Agfa CRDSC010-092021-05-17
00858012005236PowerLook PRO Tomo Detection and SLD, GEV1.1DSC014-01-EU2021-05-17
00858012005250PowerLook PRO Tomo Detection and SLD, GEV1.1DSC014-02-EU2021-05-17
00858012005809Powerlook PRO Hardware Upgrade, SLDV7.2DSC017-02-ROW2021-05-17
00858012005823Powerlook PRO Hardware Upgrade, SLDV7.2DSC017-03-ROW2021-05-17
00858012005830PowerLook AMP PRO, SLD, GE, ROWV7.2DSC017-01-ROW2021-05-17
00858012005847PowerLook AMP PRO, SLD, GE, ROWV7.2DSC017-04-ROW2021-05-17
00858012005960ProFound AI2.12019-07-11
00858012005007SecondLook Digital (SLD)V7.2DS02062014-09-22

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Primary DI, Brand, Company table
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00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
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