Olea Sphere V3.0 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images are acquired through DICOM compliant imaging devices and modalities.

Olea Sphere V3.0 provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including a Diffusion Weighted MRI (DWI) / Fiber Tracking Module and a Dynamic Analysis Module (e.g. dynamic exogenous or endogenous contrast enhanced imaging data for MRI and CT). The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. The Fiber Tracking feature utilizes the directional dependency of the white matter structure in the brain or more generally the central nervous system.

The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast while repeating acquisitions (e.g. over time without variable acquisition parameters) where such techniques are useful or necessary. This functionality is referred to as:

Perfusion Module - the calculation of parameters related to tissue flow (perfusion) and tissue blood volume.

Permeability Module - the calculation of parameters related to leakage of injected contrass material from intravascular to extracellular space.

Arterial Spin Labeling (ASL) Module - the calculation of parameters related to tissue flow based on a MR technique using the water in arterial blood as endogenous tracer to evaluate the perfusion.

Relaxometry Module - the calculation of parameters related to the MR longitudinal and transversal relaxation time and rate.

Metabolic Module - the calculation of parameters related to the fat fraction based on a MR technique using opposedphase imaging.

Device Description

Olea Sphere V3.0 is a medical viewing, analysis and processing, Picture Archiving Communications System (PACS) software, compliant with the DICOM standard and running on Windows or Linux operating systems.

Olea Sphere V3.0 allows the display, analysis and post-processing of medical images. These images, when interpreted by a trained physician, may yield clinically useful information.

The software provides a wide range of basic image processing and manipulation functions, in addition to comprehensive dynamic image processing and display. The main features of the software are:

Image Loading & Saving
Image Viewing
Image Manipulation
Image Analysis
Imaging Processing
Perfusion post-processing
Permeability post-processing
Arterial Spin Labeling (ASL)
Diffusion-Weighted Imaging (DWI) / Tensor Imaging post-processing (DTI) / Intra-Voxel Incoherent Motion (IVIM)
Fiber Tracking post-processing
Collage
Relaxometry post-processing
Metabolic post-processing

Depending on the purpose of the imaging, the following optional plug-in are used by the software:

DWI (for MR imaging)
DTI (for MR imaging)
Perfusion (for MR and CT imaging)
Permeability (for MR and CT imaging)
Kinetics (for MR imaging)
ASL (for MR imaging)
Analysis (for MR and CT imaging)
Olea Vision (for MR imaging)
IVIM (for MR imaging)
Collage (for MR imaging)
Metabolic (for MR imaging)
Relaxometry (for MR imaging)

The main users of the program are medical imaging professionals who need to visualize and analyze images acquired primarily with MRI or CT systems. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations

AI/ML Overview

The provided text describes Olea Sphere V3.0, an image processing software package, and its substantial equivalence to predicate devices, but it does not contain the detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the format requested.

The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to previously cleared devices rather than a standalone clinical study with detailed performance metrics against specific acceptance criteria.

Therefore, the following information is not available in the provided text:

A table of acceptance criteria and reported device performance.
Sample sizes used for the test set and data provenance (country of origin, retrospective/prospective).
Number of experts used to establish ground truth and their qualifications.
Adjudication method for the test set.
Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size of AI assistance.
The type of ground truth used (e.g., pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

The document states that "Internal verification and validation testing confirms that the product specifications are met, in support of the substantial equivalence of the intended use and technological characteristic as the predicate devices." It also lists the main groups of tests performed as: Product Risk Assessment, Software modules verification tests, and Software validation test. However, it does not provide the specifics of these tests or their results in terms of acceptance criteria.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 3, 2016

Olea Medical % Ms. Caroline Lene Ouality and Regulatory Affairs Manager 93 avenue des Sorbiers, Zone Athelia IV La Ciotat, 13600 FRANCE

Re: K152602

Trade/Device Name: Olea Sphere V3.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 11, 2016 Received: February 11, 2016

Dear Ms. Lene:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Oals

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Image /page/2/Picture/4 description: The image shows a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '152602'. The characters are all in a simple, sans-serif font and are evenly spaced.

Device Name Olea Sphere V3.0

Indications for Use (Describe)

Perfusion Module - the calculation of parameters related to tissue flow (perfusion) and tissue blood volume.

Permeability Module - the calculation of parameters related to leakage of injected contrass material from intravascular to extracellular space.

Arterial Spin Labeling (ASL) Module - the calculation of parameters related to tissue flow based on a MR technique using the water in arterial blood as endogenous tracer to evaluate the perfusion.

Relaxometry Module - the calculation of parameters related to the MR longitudinal and transversal relaxation time and rate.

Metabolic Module - the calculation of parameters related to the fat fraction based on a MR technique using opposedphase imaging.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED,

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/4/Picture/0 description: The image contains the logo for Olea Medical. The logo consists of a purple and orange cube with a white figure on each side. To the right of the cube is the text "Olea" in purple and "MEDICAL" in orange.

Section 7 – 510(k) Summary

(in accordance with 21 CFR 807.92)

510(k) Number K

I. Applicant Information

Applicant:	Olea Medical93 avenue des Sorbiers, Zone Athelia IVLa Ciotat 13600France
Contact Person:	Caroline LénéQuality and Regulatory Affairs ManagerTel: (011) 33 4 42 71 24 20Fax: (011) 33 4 42 71 24 27e-mail: caroline.lene@olea-medical.com
Application Correspondent:	Olea Medical93 avenue des Sorbiers, Zone Athelia IVLa Ciotat 13600France
Contact Person:	Caroline LénéQuality and Regulatory Affairs ManagerTel: (011) 33 4 42 71 24 20Fax: (011) 33 4 42 71 24 27e-mail: caroline.lene@olea-medical.com
Date Prepared:	September 9, 2015

Device Identification

Proprietary Name:	Olea Sphere V3.0
-------------------	------------------

Proprietary Name:	Olea Sphere V3.0
Common/Usual Name:	PACS
Classification Name:	Picture Archiving Communications System
Regulation Number:	21 CFR 892.2050
Product Codes:	LLZ
Classification:	Class II
Classification Panel:	Radiology Devices

II.

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III. Predicate Devices

The Olea Sphere V3.0 device is substantially equivalent to the following FDA cleared predicate device with regard to indications for use, performance and technological characteristics:

1)

510(k) Number:	K132095
Trade Name:	Olea Sphere V2.3
Manufacturer:	Olea Medical
Classification Name:	Picture Archiving Communications System
Common/Usual Name:	PACS
Regulation Number:	21 CFR 892.2050
Product Code:	LLZ
Classification:	Class II

Additionally, the software architecture of some of the new features introduced in the Olea Sphere V3.0 is essentially identical to the architecture used by the following FDA cleared predicate devices:

2)

510(k) Number:	K121434
Trade Name:	Software Syngo MR D13A for the Magnetom
	Systems Aera/Skyra/Avanto/Verio
Manufacturer:	Siemens Medical Solutions, Inc.
Classification Name:	System, Nuclear Magnetic Resonance Imaging
	Common/Usual Name: Magnetic Resonance Diagnostic Device
Regulation Number:	21 CFR 892.1000
Product Code:	LNH
Classification:	Class II

510(k) Number:	K130749
Trade Name:	Syngo.MR General; Syngo.MR Cardiology;Syngo.MR Vascular
Manufacturer:	Siemens Medical Solutions USA, Inc.
Classification Name:	Picture Archiving Communications System
Common/Usual Name:	PACS
Regulation Number:	21 CFR 892.2050
Product Code:	LLZ
Classification:	Class II

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510(k) Number: K141977 Magnetom Aera with Software Syngo MR E11A, Trade Name: Magnetom Skyra with Software Syngo MR E11A, Magnetom Skyra with 24 RF Channel Manufacturer: Siemens Medical Solutions USA, Inc. Classification Name: Class II: Magnetic Resonance Imaging System Common/Usual Name: Magnetic Resonance Diagnostic Device Regulation Number: 21 CFR 892.1000 Product Code: LNH Classification: Class II

IV. Device Description

Olea Sphere V3.0 allows the display, analysis and post-processing of medical images. These images, when interpreted by a trained physician, may yield clinically useful information.

The software provides a wide range of basic image processing and manipulation functions, in addition to comprehensive dynamic image processing and display. The main features of the software are:

Image Loading & Saving ●
Image Viewing .
Image Manipulation ●
Image Analysis .
Imaging Processing ●
Perfusion post-processing ●
Permeability post-processing
Arterial Spin Labeling (ASL) ●
· Diffusion-Weighted Imaging (DWI) / Tensor Imaging post-processing (DTI) / Intra-Voxel Incoherent Motion (IVIM)
· Fiber Tracking post-processing
· Collage
· Relaxometry post-processing
· Metabolic post-processing

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Image /page/7/Picture/0 description: The image is a logo for Olea Medical. The logo consists of a cube with two visible faces. The left face is purple and has a white, abstract image of a person made of circles. The right face is orange and has a white silhouette of a person. To the right of the cube is the text "Olea" in purple and "Medical" in orange.

Depending on the purpose of the imaging, the following optional plug-in are used by the software:

DWI (for MR imaging) .
DTI (for MR imaging) .
Perfusion (for MR and CT imaging) ●
Permeability (for MR and CT imaging)
Kinetics (for MR imaging) .
ASL (for MR imaging) .
Analysis (for MR and CT imaging) ●
Olea Vision (for MR imaging) ●
IVIM (for MR imaging) ●
Collage (for MR imaging) .
Metabolic (for MR imaging) .
Relaxometry (for MR imaging) .

V. Indications for Use Statement

Olea Sphere V3.0 is an image processing software package to be used by trained professionals including, but not limited to, physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.

The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. The Fiber Tracking feature utilizes the directional dependency of the diffusion to display the white matter structure in the brain or more generally the central nervous system.

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Image /page/8/Picture/0 description: The image is a logo for Olea Medical. The logo consists of a purple and orange hexagon with a white figure inside. To the right of the hexagon is the text "Olea" in purple and "Medical" in orange.

The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast while repeating acquisitions (e.g., over time with or without variable acquisition parameters) where such techniques are useful or necessary. This functionality is referred to as:

Perfusion Module - the calculation of parameters related to tissue flow (perfusion) and tissue blood volume.

Permeability Module - the calculation of parameters related to leakage of injected contrast material from intravascular to extracellular space.

Arterial Spin Labeling (ASL) Module - the calculation of parameters related to tissue flow based on a MR technique using the water in arterial blood as endogenous tracer to evaluate the perfusion.

Relaxometry Module - the calculation of parameters related to the MR longitudinal and transversal relaxation time and rate.

Metabolic Module - the calculation of parameters related to the fat signal fraction based on a MR technique using opposed-phase imaging.

VI. Summary of the Technical Characteristics

Olea Sphere V3.0 is a PACS software designed to access series of MRI and CT images in DICOM format, which can be used to perform image viewing, processing, image collage and analysis of medical images. The system utilizes the information contained in each image meta-data to compare images and to perform zoom, pan and crop functions.

Olea Sphere V3.0 offers a viewing and analysis module that allows to display simultaneously available DICOM image datasets and to save the results into the DICOM database.

Olea Sphere V3.0 offers four types of display for a particular data set:

1. The multi-slice view displays simultaneously all the images of selected series in tabular format where rows represent image series and columns represent cross-sectional levels;
1. The mono-slice view displays simultaneously one image of selected series at a given slice location;

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Image /page/9/Picture/0 description: The image contains the logo for Olea Medical. The logo consists of a purple and orange cube with a white figure on the orange side and a white molecular structure on the purple side. To the right of the cube is the text "Olea" in purple and "Medical" in orange.

1. The MPR/3D view displays selected series in a 3-dimensional projections; and
1. The follow-up view displays images of series acquired over time.

The system allows the calculation of surfaces and volumes over a set of images by using "segmentation masks". This also allows the user to optimize selected images by customizing the segmentation masks based on user defined areas and to save the results of this image optimization into PDF format files.

The following Predicate Devices Comparison Table provides a summary of the comparison between the Olea Sphere V3.0 and the predicate devices listed in Section III, with respect to indications for use, environment of use, intended use and limitations of use, principles of operation and performance characteristics.

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Image /page/10/Picture/0 description: The image is a logo for Olea Medical. The logo consists of a purple and orange hexagon with a stylized human figure inside. The word "Olea" is written in purple, and the word "Medical" is written in orange below it. The hexagon is divided into two sections, with the left side being purple and the right side being orange. The purple side contains a series of white circles, and the orange side contains a white human figure.

Predicate Device Comparison Table

Device Name	Subject Device:Olea Sphere V3.0	Predicate #1:(K132095)Olea Sphere (V2.3)	Predicate #2:(K121434)Software SyngoMR D13A for theMagnetom SystemsAera/Skyra/Avanto/Verio	Predicate #3:(K130749)Syngo.MRGeneral;Syngo.MRCardiology;Syngo.MRVascular	Predicate #4:(K141977)Magnetom Aerawith SoftwareSyngo MR E11A,Magnetom Skyrawith SoftwareSyngo MR E11A,Magnetom Skyrawith 24 RFChannel	SignificantDifferences
Product Code	LLZ	LLZ	LNH	LLZ	LNH	The subject device
Regulation #	892.2050	892.2050	892.1000	892.2050	892.1000	and predicates #1and #3 are classifiedas Product CodeLLZ underregulation 892.1000whereas predicates#2 and #4 areclassified as ProductCode LNH, underregulation 892.1000.
Class	II	II	II	II	II	No difference.
Indications	Olea Sphere V3.0 is	Olea Sphere is an	The Magnetom	The software	The Magnetom	Olea Sphere V3.0
for Use	an image processingsoftware package to	image processingsoftware package to	systemsAera/Skyra/Avanto/	comprising thesyngo.MR post-	systems [MagnetomAera and Magnetom	and Olea SphereV2.3 (predicate #1)

be used by trainedprofessionals	be used by trainedprofessionals	Verio with softwaresyngo MR D13A are	processingapplications are	Skyra] are indicated	have essentially an
including but not	including but not	indicated for use as	post-processing	for use as a magnetic	identical Indication
limited to physicians	limited to physicians	magnetic resonance	software/applicati	resonance diagnostic	for Use, with the
and medical	and medical	diagnostic devices	ons to be used for	device (MRDD) that	exception that Olea
technicians. The	technicians. The	(MRDD) that	viewing and	produces transverse,	Sphere V2.3 does
software runs on a	software runs on a	produce transverse,	evaluating the	sagittal, coronal and	not include ASL,Collage,
standard "off-the-	standard "off-the-	sagittal, coronal and	designated images	oblique cross	Relaxometry and
shelf" workstation	shelf" workstation	oblique cross-	provided by a	sectional images,	Metabolic analysis
and can be used to	and can be used to	sectional images,	magnetic	spectroscopic images	capabilities (see
perform image	perform image	spectroscopic images	resonance	and/or spectra, and	parts in yellow ).
viewing, processing,	viewing, processing	and/or spectra, and	diagnostic device.	that displays the
image collage and	and analysis of	that display the	All of the	internal structure	With respect to ASL
analysis of medical	medical images.	internal structure	software	and/or function of	analysis, Olea
images. Data and	Data and images are	and/or function of	applications	the head, body, or	Sphere V3.0 and th
images are acquired	acquired through	the head, body, or	comprising the	extremities.	Software Syngo M
through DICOM	DICOM compliant	extremities. Other	syngc.MR post-	Other physical	D13A predicate #2
compliant imaging	imaging devices and	physical parameters	processing	parameters derived	have substantially
devices and	modalities.	derived from the	applications have	from the images	equivalent
modalities.		images and/or	their own	and/or spectra may	indications for use.
Olea SphereV3.0	Olea Sphere	spectra may also be	indications for	also be produced.
provides both	provides both	produced.	use.	Depending on the	With respect to the
viewing and analysis	viewing and analysis	Depending on the		region of interest,	Collage feature
capabilities of	capabilities of	region of interest,	Syngo.MR	contrast agents may	Olea Sphere V3.0
functional and	functional and	contrast agents may	General: is a	be used. These	and the Syngo.MR
dynamic imaging	dynamic imaging	be used.	syngo based post-	images and/or	General predicate #
datasets acquired	datasets acquired	These images and/or	processing	spectra and the	have substantially
with MRI or other	with MRI or other	spectra and the	software for	physical parameters	equivalent
relevant modalities,	relevant modalities,	physical parameters	viewing,	derived from the	indications for use.
including a	including a	derived from the	manipulating, and	images and/or
	Diffusion WeightedMRI (DWI) / FiberTracking Moduleand a DynamicAnalysis Module(e.g. dynamicexogenous orendogenous contrastenhanced imagingdata for MRI andCT).The DWI Module isused to visualizelocal water diffusionproperties from theanalysis of diffusion-weighted MRI data.The Fiber Trackingfeature utilizes thedirectionaldependency of thediffusion to displaythe white matterstructure in the brainor more generallythe central nervoussystem.The DynamicAnalysis Module isused for	Diffusion WeightedMRI (DWI) / FiberTracking Moduleand a DynamicAnalysis Module(dynamic contrastenhanced imagingdata for MRI andCT).The DWI Module isused to visualizelocal water diffusionproperties from theanalysis of diffusion-weighted MRI data.The Fiber Trackingfeature utilizes thedirectionaldependency of thediffusion to displaythe white matterstructure in the brainor more generallythe central nervoussystem.The DynamicAnalysis Module isused for	images and/orspectra, wheninterpreted by atrained physician,yield informationthat may assist indiagnosis.The Magnetomsystems may also beused for imagingduring interventionalprocedures whenperformed with MRcompatible devicessuch as in-roomdisplay and MR-safebiopsy needles.	evaluating MRimages.Syngo.MRCardiology: is asyngo based post-processingsoftware forviewing,manipulating, andevaluating MRcardiac images.Syngo.MRVascular: is asyngo based post-processingsoftware forviewing,manipulating, andevaluating MRvascular images.	interpreted by atrained physician,yield informationthat may assist indiagnosis.The Magnetomsystems may also beused for imagingduring interventionalprocedures whenperformed with MRcompatible devicessuch as in-roomdisplay and MR-Safebiopsy needles.	With respect to theRelaxometry andMetabolic analysis,Olea Sphere V3.0and Magnetom Aerawith SoftwareSyngo MR E11Apredicate #4 havesubstantiallyequivalentindications for use.

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Image /page/12/Picture/0 description: The image is a logo for Olea Medical. The logo consists of a purple and orange cube with a white silhouette of a person on the orange side and a white cluster of circles on the purple side. To the right of the cube is the text "Olea" in purple and "medical" in orange.

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visualization andanalysis of dynamicimaging data,showing propertiesof changes incontrast whilerepeatingacquisitions (e.g.over time with orwithout variableacquisitionparameters) wheresuch techniques areuseful or necessary.This functionality isreferred to as:Perfusion Module –the calculation ofparameters related totissue flow(perfusion) andtissue blood volume.Permeability Module– the calculation ofparameters related toleakage of injectedcontrast materialfrom intravascular to	visualization andanalysis of dynamicimaging data,showing propertiesof changes incontrast over timewhere suchtechniques are usefulor necessary.This functionality isreferred to as:Perfusion Module –the calculation ofparameters related totissue flow(perfusion) andtissue blood volume.Permeability Module– the calculation ofparameters related toleakage of injectedcontrast materialfrom intravascular to
extracellular space.	extracellular space.
Arterial SpinLabeling (ASL)Module - thecalculation ofparameters related totissue flow based ona MR techniqueusing the water inarterial blood asendogenous tracer toevaluate theperfusion.
Relaxometry Module- the calculation ofparameters related tothe MR longitudinaland transversalrelaxation time andrate.
Metabolic Module -the calculation ofparameters related tothe fat signal fractionbased on a MRtechnique usingopposed-phase

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	imaging.
Environmentof Use	Olea Sphere is foruse in hospitals,imaging centers,radiologist readingpractices byprofessional whorequires and isgranted access topatient image,demographic andreport information.	Olea Sphere is foruse in hospitals,imaging centers,radiologist readingpractices byprofessional whorequires and isgranted access topatient image,demographic andreport information.	Clinical/HospitalEnvironment	Clinical/HospitalEnvironment	Clinical/HospitalEnvironment	No difference.
Limitations ofUse/IntendedUse	Lossy compressedmammographicimages and digitizedfilm screen imagesmust not bereviewed for primaryimageinterpretations.	Lossy compressedmammographicimages and digitizedfilm screen imagesmust not bereviewed for primaryimageinterpretations.	Indicated for use as amagnetic resonancediagnostic device(MRDD).	Intended for MRvolume data sets.	Indicated for use as amagnetic resonancediagnostic device(MRDD).	No difference. OleaSphere V3.0 andOlea Sphere V2.3(predicate #1) havethe same limitationsof use.The Olea SphereV3.0 ASL, Collage,Relaxometry andMetabolic analysisfeatures have thesame limitation ofuse (i.e. magneticresonanceimaging) aspredicates #2, #3and #4 respectively
Principles ofOperation	The Olea Sphere	The Olea Sphere	It provides both the	Syngo.MR	Software Syngo MR	Olea Sphere V3.0and Olea SphereV2.3 (predicate #1)
	software offerscomprehensivefunctionality fordynamic imageanalysis andvisualization, wheresignal changes overtime are analyzed todetermine variousmodality dependentfunctionalparameters.Olea Sphereprovides bothviewing and analysiscapabilities offunctional anddynamic imagingdatasets acquiredwith MRI or otherrelevant modalities,including diffusionweighted MRI(DWI) / fibertracking, anddynamic analysis(e.g. dynamic	software offerscomprehensivefunctionality fordynamic imageanalysis andvisualization, wheresignal changes overtime are analyzed todetermine variousmodality dependentfunctionalparameters.Olea Sphereprovides bothviewing and analysiscapabilities offunctional anddynamic imagingdatasets acquiredwith MRI or otherrelevant modalities,including diffusionweighted MRI(DWI) / fibertracking, anddynamic analysis(dynamic contrast	MR techniqueacquisition and themap generation post-processing software.Syngo ASL (ArterialSpin Labeling) is anMR technique usingthe water in arterialblood as anendogenous contrastagent to evaluateperfusion non-invasively. SyngoASL provides arobust PulsedArterial SpinLabeling sequencewhich provides in-line calculation ofCBF maps from theacquired data.	Syngo.MRComposing(optional) is anoffline applicationfor creation offull-formatimages fromoverlapping MRvolume data setsacquired atmultiple stages.	Software Syngo MRE11A for theMagnetom SystemsAera/Skyra offerstwo newapplications,LiverLab (anapplication of non-invasive liverevaluation) andMyoMaps (anapplication designedto provide a meansto generate pixelmaps for myocardialMR relaxationtimes).	have essentiallyidentical principlesof operation, withthe exception thatOlea Sphere V2.3does not include theASL, Collage,Relaxometry andMetabolic analysis(see parts inyellow).With respect to theASL analysis, OleaSphere V3.0 andSoftware Syngo MRD13A (predicate #2)have substantiallyequivalent principlesof operation, withthe minor exceptionthat Olea SphereV3.0 does notprovide the MRacquisitiontechnique, but only

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Image /page/16/Picture/0 description: The image is a logo for Olea Medical. The logo consists of a purple and orange hexagon with a white figure inside. The word "Olea" is written in purple, and the word "Medical" is written in orange below it. The logo is simple and modern, and it is likely used to represent a medical company or organization.

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Image /page/17/Picture/0 description: The image is a logo for Olea Medical. The logo consists of a hexagon split into two colors, purple and orange. The purple side has a graphic of a person made of circles, and the orange side has a graphic of a person. To the right of the hexagon is the text "Olea" in purple and "Medical" in orange.

exogenous orendogenous contrastenhanced imagingdata for MRI andCT).	enhanced imagingdata for MRI andCT).		the map generationpost-processingsoftware.
DWI / FiberTracking Module:Diffusion analysis isused to visualizelocal water diffusionproperties from theanalysis of diffusion-weighted MRI data.Fiber trackingutilizes thedirectionaldependency of thediffusion to displaythe white matterstructure in the brainor more generallythe central nervoussystem.	DWI / FiberTracking Module:Diffusion analysis isused to visualizelocal water diffusionproperties from theanalysis of diffusion-weighted MRI data.Fiber trackingutilizes thedirectionaldependency of thediffusion to displaythe white matterstructure in the brainor more generallythe central nervoussystem.		With respect to theCollage featureOlea Sphere V3.0and Syngo.MRGeneral (predicate#3) havesubstantiallyequivalent principlesof operation, withthe minor exceptionthat the Olea SphereV3.0 imagecomposing is notnecessarily offline.
Dynamic Analysis:Dynamic analysis isused forvisualization andanalysis of dynamic	Dynamic Analysis:Dynamic analysis isused forvisualization andanalysis of dynamic		With respect to theRelaxometry andMetabolic analysis,Olea Sphere V3.0and Magnetom Aerawith SoftwareSyngo MR E11A(predicate #4) havesubstantiallyequivalent principlesof operation.

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Image /page/18/Picture/0 description: The image is a logo for Olea Medical. The logo consists of a hexagon split into two colors, purple and orange. On the purple side, there is a cluster of white dots, and on the orange side, there is a white silhouette of a person. To the right of the hexagon is the text "Olea" in purple and "medical" in orange.

imaging, showingproperties ofchanges in contrastwhile repeatingacquisitions (e.g.over time with orwithout variableacquisitionparameters) wheresuch techniques areuseful or necessary.This functionalityincludes dedicatedanalysis methodsand visualizationtools for dynamiccontrast enhancedimaging data (fromMRI or CT) where abolus injection of acontrast agentmaterial results in atemporal change inthe signal intensity.This dynamicchange in signalintensity is used tocalculate functionalparameters related totissue flow	imaging, showingproperties ofchanges in contrastover time wheresuch techniques areuseful or necessary.This functionalityincludes dedicatedanalysis methodsand visualizationtools for dynamiccontrast enhancedimaging data (fromMRI or CT) where abolus injection of acontrast agentmaterial results in atemporal change inthe signal intensity.This dynamicchange in signalintensity is used tocalculate functionalparameters related totissue flow
(perfusion) andtissue blood volumeas well as leakage(due to capillarypermeability) of theinjected contrastmaterial from theintravascular to theextracellular space.This functionality isreferred to as:Perfusion Module:Calculation ofparameters related totissue flow(perfusion) andtissue blood volume.PermeabilityModule: Calculationof parameters relatedto leakage ofinjected contrastmaterial fromintravascular toextracellular space.This functionalityalso includes	(perfusion) andtissue blood volumeas well as leakage(due to capillarypermeability) of theinjected contrastmaterial from theintravascular to theextracellular space.This functionality isreferred to as:Perfusion Module:Calculation ofparameters related totissue flow(perfusion) andtissue blood volume.PermeabilityModule: Calculationof parameters relatedto leakage ofinjected contrastmaterial fromintravascular toextracellular space.

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Image /page/19/Picture/0 description: The image is a logo for Olea Medical. The logo consists of a hexagon split into two colors, purple and orange. On the purple side, there is a cluster of white dots, and on the orange side, there is a white silhouette of a person. To the right of the hexagon, the word "Olea" is written in purple, and below it, the word "Medical" is written in orange.

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Image /page/20/Picture/0 description: The image contains the logo for Olea Medical. The logo consists of a purple and orange hexagon with a human figure inside. To the right of the hexagon is the text "Olea" in purple and "medical" in orange.

dedicated analysismethods andvisualization toolsfor MR techniqueusing the water inarterial blood asendogeneous tracerto visualize tissueperfusion andevaluate blood flownon-invasively. Thisfunctionality isreferred to as:Arterial SpinLabeling (ASL)Module - thecalculation ofparameters related totissue flow based ona MR techniqueusing the water inarterial blood asendogenous tracer toevaluate theperfusion.This functionalityalso includesdedicated analysis
methods andvisualization toolsfor MR techniqueusing intrinsic tissueproperties tovisualize andevaluate tissuerelaxation times andfat signal fraction.This functionality isreferred to as:Relaxometry Module– the calculation ofparameters related tothe MR longitudinaland transversalrelaxation time andrate.Metabolic Module –the calculation ofparameters related tothe fat signal fractionbased on a MRtechnique usingopposed-phaseimaging.

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Image /page/21/Picture/0 description: The image shows the logo for Olea Medical. The logo consists of a purple and orange cube with a white figure on each side. To the right of the cube is the word "Olea" in purple and the word "medical" in orange.

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Image /page/22/Picture/0 description: The image is a logo for Olea Medical. The logo consists of a purple and orange hexagon with a white figure inside. To the right of the hexagon is the text "Olea" in purple and "medical" in orange.

PerformanceFeatures	Main softwarefeatures:	Main softwarefeatures:	Main softwarefeatures:	Main softwarefeatures:	Main softwarefeatures:	Olea Sphere V3.0 performs in a substantially equivalent manner to the Olea Sphere V2.3 (predicate #1), with the exception that Olea Sphere V2.3 does not include the ASL, Collage, Relaxometry and Metabolic features (see parts in yellow).Additionally, Olea Sphere V3.0 enhances the Diffusion Weighted Imaging with the addition of the Intra-Voxel Incoherent Motion analysis.Additionally, Olea Sphere V3.0 includes the Kinetics analysis.
	Image Loading & Saving Image Viewing Image Manipulation Image Analysis Imaging Processing Perfusion post-processing Permeability post-processing Kinetics post-processing Arterial spin labeling Diffusion-Weighted Imaging / Tensor Imaging post-processing / Intra-Voxel Incoherent Motion Fiber Tracking post-processing	Image Loading & Saving; Image Viewing; Image Manipulation; Image Analysis; Imaging Processing; Perfusion Maps; Permeability Maps; Diffusion Weighted Imaging/Tensor Imaging Maps; Fiber Tracking.	Arterial spin labeling	Collage (composing)	Relaxometry post-processing Metabolic post-processing

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Image /page/23/Picture/0 description: The image contains the logo for Olea Medical. The logo consists of a cube-like shape with two visible faces. The left face is purple and contains a pattern of white circles. The right face is orange and contains a white silhouette of a person. To the right of the cube is the text "Olea" in purple and "MEDICAL" in orange.

Collage(composing) Relaxometrypost-processing Metabolic post-processing			which is a subset offeatures alreadyincluded in thePermeabilityanalysis of OleaSphere V2.3.With respect to theOlea Sphere V3.0ASL, Collage,Relaxometry andMetabolic features,they perform in asubstantiallyequivalent mannerto their respectivepredicates (predicate#2, #3 and #4).
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Image /page/24/Picture/0 description: The image contains the logo for Olea Medical. The logo consists of a purple and orange cube with a white figure on the orange side and white circles on the purple side. To the right of the cube is the text "Olea" in purple and "Medical" in orange.

VII. Summary of Performance Data

Olea Medical has conducted extensive validation testing of the Olea Sphere V3.0 system, as a PACS that is capable of providing reliable post-processing and display of images for instantaneous multi-parametric analysis. Internal verification and validation testing confirms that the product specifications are met, in support of the substantial equivalence of the intended use and technological characteristic as the predicate devices.

All of the different components of the Olea Sphere V3.0 software have been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate according to its intended use and in a manner substantially equivalent to the predicate devices.

The main groups of tests nerformed include:

. Product Risk Assessment
Software modules verification tests
Software validation test

Substantial Equivalence Conclusions VIII.

Based on the comparison of intended use, principles of operation and technological characteristics, the Olea Sphere V3.0 system is substantially equivalent to the Olea Sphere V2.3 software manufactured by Olea Medical (K132095).

Additionally the software architecture of many of the features of the Olea Sphere V3.0 is essentially identical to the architecture used by other predicates: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/ Verio manufactured by Siemens Medical Solutions, Inc. (K121434), Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vascular manufactured by Siemens Medical Solutions USA, Inc. (K130749), and Magnetom Aera with Software Syngo MR E11A. Magnetom Skyra with Software Syngo MR E11A, Magnetom Skyra with 24 RF Channel manufactured by Siemens Medical Solutions USA, Inc. (K141977).

The minor technological differences between the Olea Sphere V3.0 and its predicate devices raise no new issues of safety or effectiveness. The performance and validation data demonstrate that the Olea Sphere V3.0 is as safe and effective as the predicate devices.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).