CAKE

Primary DI
00864747000231
Brand
CAKE
Company
NEOSOFT LLC
Model
3.0.0
Device description
NeoSoft’s CAKE product is a post-processing, productivity software package designed to assist radiologists in the analysis of dynamic breast MR images. The software provides image display, supplemental information and visual enhancement of time/intensity changes extracted from MR temporal datasets. Single or multi-slice datasets, using standard acquisition protocols, are used for input.The results may be displayed as either a grayscale enhancement or a color overlay on the selected image. CAKE may perform additional functions to aid in the analysis and viewing of dynamic studies including registration of serial MR acquisitions, labeling of tissue types based upon user specified enhancement characteristics, visualization and quantification of lesion morphology in 3D, segmentation of tissues, multi-planar reformats, maximum intensity projections, image averaging, and subtractions.When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made based solely on the results of CAKE analysis.
Published
2018-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K080196000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080196000Z3D CONTRAST ACUITYClario Medical Imaging, Inc.2008-09-05LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864747000231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864747000231008647470002318647470002310864747000231

GMDN Terms#

Term, Definition table
TermDefinition
MRI system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a magnetic resonance imaging (MRI) 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 programs or program packages must be combined with specific hardware or firmware 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

Regulatory Flags#

DUNS number
079151785
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850001088008suiteHEART4.0.72018-11-21
00850001088015suiteHEART52019-07-15
00864747000279suiteHEART4.0.62018-05-29
00864747000200suiteHEART3.0.12016-05-23
00864747000217suiteHEART4.0.02016-11-23
00864747000224suiteHEART4.0.12017-01-24
00864747000248suiteHEART 4.0.22017-05-30
00864747000255suiteHEART4.0.32017-07-24
00864747000262suiteHEART4.0.42017-11-13

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