← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K152602 # Olea Sphere V3.0 (K152602) _Olea Medical · LLZ · Mar 3, 2016 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K152602 ## Device Facts - **Applicant:** Olea Medical - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Mar 3, 2016 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Software as a Medical Device ## Intended Use 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. Olea SphereV3.0 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 diffusion to display 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 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. ## Device Story Olea Sphere V3.0 is a DICOM-compliant PACS software package for medical image viewing, analysis, and post-processing. It runs on standard off-the-shelf workstations in hospitals and imaging centers. The software processes functional and dynamic imaging datasets (MRI/CT) to generate clinical parameters. Key modules include: DWI/Fiber Tracking (visualizing water diffusion and white matter structure); Perfusion/Permeability (calculating tissue flow, blood volume, and contrast leakage); ASL (evaluating perfusion using arterial blood water); Relaxometry (calculating relaxation times/rates); and Metabolic analysis (fat signal fraction). Physicians and technicians use the software to manipulate images, perform multi-slice/3D/follow-up viewing, and generate segmentation masks for volume/surface calculations. The output assists clinicians in diagnosis by providing quantitative functional data derived from temporal signal intensity changes or diffusion properties. The device benefits patients by enabling advanced non-invasive assessment of tissue characteristics and blood flow. ## Clinical Evidence Bench testing only. Validation included product risk assessment, software module verification, and software validation testing to confirm product specifications and performance equivalence to predicates. ## Technological Characteristics PACS software for Windows/Linux; DICOM-compliant; utilizes image metadata for processing (zoom, pan, crop, segmentation). Features include multi-slice, mono-slice, MPR/3D, and follow-up views. Modules perform post-processing for DWI, DTI, IVIM, Perfusion, Permeability, ASL, Relaxometry, and Metabolic analysis. Standalone software on off-the-shelf workstations. ## Regulatory 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. ## Special Controls *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). ## Predicate Devices - Olea Sphere V2.3 ([K132095](/device/K132095.md)) - Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio ([K121434](/device/K121434.md)) - Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vascular ([K130749](/device/K130749.md)) - Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A, Magnetom Skyra with 24 RF Channel ([K141977](/device/K141977.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the smallest and the bottom profile being the largest. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) 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. 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) {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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 Medical
93 avenue des Sorbiers, Zone Athelia IV
La Ciotat 13600
France | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Caroline Léné
Quality and Regulatory Affairs Manager
Tel: (011) 33 4 42 71 24 20
Fax: (011) 33 4 42 71 24 27
e-mail: caroline.lene@olea-medical.com | | Application Correspondent: | Olea Medical
93 avenue des Sorbiers, Zone Athelia IV
La Ciotat 13600
France | | Contact Person: | Caroline Léné
Quality and Regulatory Affairs Manager
Tel: (011) 33 4 42 71 24 20
Fax: (011) 33 4 42 71 24 27
e-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. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a logo for Olea Medical. The logo consists of a purple and orange hexagon with a white silhouette of a person on the orange side and a white cluster of dots on the purple side. To the right of the hexagon is the word "Olea" in purple, with the word "MEDICAL" in orange underneath. ### 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 | | | | 3) | 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 | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Olea Medical. The logo consists of a purple and orange cube with a white figure inside. To the right of the cube is the text "Olea" in purple and "medical" in orange. 4) 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 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 {7}------------------------------------------------ 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) . 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 #### 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. Olea SphereV3.0 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 diffusion to display the white matter structure in the brain or more generally the central nervous system. {8}------------------------------------------------ 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; - 2. The mono-slice view displays simultaneously one image of selected series at a given slice location; {9}------------------------------------------------ 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. - 3. The MPR/3D view displays selected series in a 3-dimensional projections; and - 4. 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. {10}------------------------------------------------ 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 Syngo
MR D13A for the
Magnetom Systems
Aera/Skyra/Avanto
/Verio | Predicate #3:
(K130749)
Syngo.MR
General;
Syngo.MR
Cardiology;
Syngo.MR
Vascular | Predicate #4:
(K141977)
Magnetom Aera
with Software
Syngo MR E11A,
Magnetom Skyra
with Software
Syngo MR E11A,
Magnetom Skyra
with 24 RF
Channel | Significant
Differences | |------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | LLZ | LLZ | LNH | LLZ | LNH | The subject device | | Regulation # | 892.2050 | 892.2050 | 892.1000 | 892.2050 | 892.1000 | and predicates #1
and #3 are classified
as Product Code
LLZ under
regulation 892.1000
whereas predicates
#2 and #4 are
classified as Product
Code LNH, under
regulation 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 processing
software package to | image processing
software package to | systems
Aera/Skyra/Avanto/ | comprising the
syngo.MR post- | systems [Magnetom
Aera and Magnetom | and Olea Sphere
V2.3 (predicate #1) | | | | | | | | | | be used by trained
professionals | be used by trained
professionals | Verio with software
syngo MR D13A are | processing
applications 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… --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K152602](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K152602) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com