Who is the manufacturer of Limbus Contour?

Limbus Ai, Inc. filed the 510(k) submission for Limbus Contour (K241837).

What is the FDA product code for Limbus Contour?

QKB. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Limbus Contour?

510(k) clearance (submission type: Traditional).

Does Limbus Contour use AI or machine learning?

Yes. Limbus Contour (K241837) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like Limbus Contour?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Limbus Contour get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Limbus Contour

K241837 · Limbus Ai, Inc. · QKB · Oct 9, 2024 · Radiology

Device Facts

Record ID	K241837
Device Name	Limbus Contour
Applicant	Limbus Ai, Inc.
Product Code	QKB · Radiology
Decision Date	Oct 9, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K241837 · Oct 9, 2024	Limbus Contour	Limbus Ai, Inc.	Anonymized/pseudo-anonymized patient radiotherapy treatment planning scans; Expert-generated clinical contours; Published clinical literature (Wong et al., 2021)	Retrospective clinical data were used to train and validate machine learning models for automatic contouring. A prospective clinical study was cited to demonstrate the device's performance and clinical utility in routine practice.	Machine Learning; Automatic Contouring; Radiotherapy; Retrospective Data; Clinical Validation

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Model Training and Validation; Retrospective analysis of clinical radiotherapy treatment planning data	General population of patients receiving radiotherapy treatment; Sample Size: Exceeds 10,000 unique scans; Number of Sites: Multiple international institutions	Not applicable for this study	Anatomical segmentation accuracy (Dice Similarity Coefficient)
Wong, Huang, Wells et al., 2021; Prospective clinical evaluation	Patients undergoing RT for CNS, head and neck, or prostate cancer; Sample Size: 551 eligible cases; Number of Sites: 2 Canadian institutions	Not applicable for this study	Subjective editing scores, Dice Similarity Coefficient (DSC), 95% Hausdorff Distance (HD)

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Anatomical structure segmentation	U-Net and ResUNet CNN	Dice Similarity Coefficient > reference model's mean minus standard deviation	Mean DSC values provided per structure in performance table	Training and validation scans from anonymized/pseudo-anonymized datasets including public clinical trials and clinical/research partners. >10,000 unique scans.	>1 (in-house clinicians and radiation oncologist)	Benchtop performance testing using randomly selected patient scans not included in training or validation. 10 scans per structure.	>1 (experts at multiple institutions)

Indications for Use

Limbus Contour is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal contours for input to radiation treatment planning. Supported image modalities are Computed Tomography and Magnetic Resonance. The Limbus Contour Software assists in the following scenarios: Operates in conjunction with radiation treatment planning systems or DICOM viewing systems to load, save, and display medical images and contours for treatment evaluation and treatment planning. Creation, transformation, and modification of contours for applications including, but not limited to: transferring contours to radiotherapy treatment planning systems, aiding adaptive therapy and archiving contours for patient follow-up. Localization and definition of healthy anatomical structures. Limbus Contour is not intended for use with digital mammography.

Device Story

Limbus Contour is a standalone software application for automatic segmentation of CT/MRI DICOM images. It uses pre-trained, expert-curated machine learning models to localize and define healthy anatomical structures. The device is operated by radiation oncologists, dosimetrists, and physicists in clinical settings. It does not store or display images; it interfaces with existing radiotherapy treatment planning systems (TPS) or DICOM viewers. Users import DICOM images, and the software exports DICOM RT-Structure sets. The output assists in treatment evaluation, adaptive therapy, and patient follow-up by providing initial contours that require minimal editing, thereby reducing contouring time. The device is a locked algorithm system.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing. Performance was validated using an automatic contouring test on controlled datasets of medical scans with manual segmentations. Accuracy was measured using the Sørensen-Dice Similarity Coefficient (DSC). Results for all structures passed, with the lower edge of the 95% confidence interval for DSC exceeding the established reference thresholds derived from published literature.

Technological Characteristics

Software-only device; no physical materials or energy sources. Operates on Windows 10/Server 2016+ with 2GHz+ multicore processor and 16GB RAM (CUDA-capable NVIDIA GPU optional). Connectivity via DICOM 3.0 file system import/export. Algorithm: Locked deep learning model (U-Net/ResUNet architecture) trained via Adam optimization and Sørensen-Dice loss function.

Indications for Use

Indicated for trained radiation oncologists, dosimetrists, and physicists to derive optimal contours for radiation treatment planning using CT or MRI images. Not for use with digital mammography.

Regulatory Classification

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

Limbus Contour (K230575)

Submission Summary (Full Text)

{0}------------------------------------------------ October 9, 2024 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Limbus AI Inc. Jonathan Giambattista Director - Software 2431 Glamis Place Regina, SK S4N3K9 Canada Re: K241837 Trade/Device Name: Limbus Contour Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QKB Dated: July 15, 2024 Received: July 15, 2024 Dear Jonathan Giambattista: 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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory {2}------------------------------------------------ assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Locoa Werchner Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use Submission Number (if known) K241837 Device Name Limbus Contour Indications for Use (Describe) Limbus Contour is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal contours for input to radiation treatment planning. Supported image modalities are Computed Tomography and Magnetic Resonance. The Limbus Contour Software assists in the following scenarios: Operates in conjunction with radiation treatment planning systems or DICOM viewing systems to load, save, and display medical images and contours for treatment evaluation and treatment planning. Creation, transformation, and modification of contours for applications including, but not limited to: transferring contours to radiotherapy treatment planning systems, aiding adaptive therapy and archiving contours for patient follow-up. Localization and definition of healthy anatomical structures. Limbus Contour is not intended for use with digital mammography. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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}------------------------------------------------ # K241837 # 510(k) SUMMARY This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92: SUBMITTER -Limbus Al Inc. 2431 Glamis Pl Regina, Saskatchewan, Canada, S4V1A5 Tel: 1-306-502-5982 | Contact Person: | Jon Giambattista | |-----------------|------------------| | Date Prepared: | October 9, 2024 | | II. DEVICE | | |------------------------------|--------------------------------------| | Name of Device: | Limbus Contour | | Classification Name: | Radiological Image Processing System | | Regulation: | 21 CFR §892.2050 | | Regulatory Class: | Class II | | Product Classification Code: | QKB | III. PREDICATE DEVICE | Predicate Manufacturer: | Limbus AI, Inc. | |-------------------------|-----------------| | Predicate Trade Name: | Limbus Contour | | Predicate 510(k): | K230575 | No reference devices were used in this submission. #### IV. DEVICE DESCRIPTION Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user's operating system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files). #### V. INDICATIONS FOR USE Limbus Contour is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal contours for input to radiation treatment planning. Supported image modalities are Computed Tomography and Magnetic Resonance. The Limbus Contour Software assists in the following scenarios: - Operates in conjunction with radiation treatment planning systems to load, save, and ● display medical images and contours for treatment evaluation and treatment planning. - . Creation, transformation, and modification of contours for applications including, but not limited to: transferring contours to radiotherapy treatment planning systems, aiding adaptive therapy and archiving contours for patient follow-up. {5}------------------------------------------------ - . Localization and definition of anatomical structures. Limbus Contour is not intended for use with digital mammography. #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence: - Indications for Use The predicate and subject device are identical with the exception . that the predicate has support for MacOS while the subject device does not and the predicate has less structures for automatic contouring available. - . Materials – The predicate and subject device are software-only devices and do not inherently contain material. - Design - The predicate and subject device have equivalent designs. - . Energy Source – The predicate and subject device are software-only devices, powered by the computer system. - . Performance Testing – The predicate and subject device were both validated using an automatic contouring test to ensure the contours were accurate. | Item | Limbus Contour v1.8 | Limbus Contour v1.7 - K230575 | Similarities / Differences | |-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification Regulation | 892.2050 - Medical image management and processing system | 892.2050 - Medical image management and processing system | Same | | Product Code | QKB | LLZ | Similar; Both product codes refer to the same CFR 892.2050 - Medical image management and processing system | | Indications for Use | Limbus Contour is a software only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal contours for input to radiation treatment planning. Supported image modalities are Computed Tomography and Magnetic Resonance. The Limbus Contour Software assists in the following scenarios: • Operates in conjunction with radiation treatment planning systems or DICOM viewing systems to load, save, and display medical images and contours for treatment evaluation and treatment planning. • Creation, transformation, and modification of contours for | Limbus Contour is a software only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal contours for input to radiation treatment planning. Supported image modalities are Computed Tomography and Magnetic Resonance. The Limbus Contour Software assists in the following scenarios: • Operates in conjunction with radiation treatment planning systems or DICOM viewing systems to load, save, and display medical images and contours for treatment evaluation and treatment planning. • Creation, transformation, and modification of contours for | Same | | Item | Limbus Contour v1.8 | Limbus Contour v1.7 - K230575 | Similarities / Differences | | | applications including, but not limited to: transferring contours to radiotherapy treatment planning systems, aiding adaptive therapy and archiving contours for patient follow-up. • Localization and definition of healthy anatomical Structures. Limbus Contour is not intended for use with digital mammography. | applications including, but not limited to: transferring contours to radiotherapy treatment planning systems, aiding adaptive therapy and archiving contours for patient follow-up. • Localization and definition of healthy anatomical Structures. Limbus Contour is not intended for use with digital mammography. | | | Intended User | Healthcare providers | Healthcare providers | Same | | Machine Learning Algorithm | Locked algorithm; Deep Learning model | Locked algorithm; Deep Learning model | Same | | Contouring Modes | Automatic | Automatic | Same | | Supported Image Modalities | CT; MR | CT; MR | Same | | Compatible Scanner Models | No Limitation on scanner model, DICOM 3.0 compliance required. | No Limitation on scanner model, DICOM compliance required. | Same | | Compatible Treatment Planning System | No Limitation on TPS model | No Limitation on TPS model | Same | | Result Visualization | Limbus Contour has no data visualization. Data processing is automated and does not require user interaction. A control interface is provided for system administration and configuration only. Visualization software must be used to facilitate the review and edit of the generated contours. | Limbus Contour has no data visualization. Data processing is automated and does not require user interaction. A control interface is provided for system administration and configuration only. Visualization software must be used to facilitate the review and edit of the generated contours. | Same | | Structures Available for Contouring | CT Structures • A_Aorta • A_Aorta_I • A_Celiac • A_LAD • A_Mesenteric_S • A_Pulmonary • Bag_Bowel • Bag_Bowel_Extend • Bag_Bowel_Full • Bag_Bowel_S • Bladder • Body • Bone_Hyoid | CT Structures • A_Aorta • A_Aorta_Base • A_Aorta_I • A_Celiac • A_LAD • A_Mesenteric_S • A_Pulmonary • Atrium_L • Atrium_R • Bowel_Bag • Bowel_Bag_Extend • Bowel_Bag_Full • Bowel_Bag_Superior | Similar; The subject device adds new structures for existing supported image modalities (CT/MR) | | Item | Limbus Contour v1.8 | Limbus Contour v1.7 - K230575 | Similarities / Differences | | | Bone_Ilium_L Bone_Ilium_R Bone_Ilium Bone_Mandible Bowel Bowel_Extend Bowel_Full Bowel_S BrachialPlex_L BrachialPlex_R BrachialPlexs Brain Brainstem Breast_L Breast_R Breasts Bronchus Canal_Anal CaudaEquina Cavity_Oral Chestwall_L Chestwall_R Chestwalls Clavicle_L Clavicle_R Cochlea_L Cochlea_R Colon_Sigmoid Cornea_L Cornea_R Duodenum Esophagus Eye_L Eye_R Eyes Femur_Head_L Femur_Head_R Femur_Heads Gallbladder Glnd_Lacrimal_L Glnd_Lacrimal_R Glnd_Submand_L Glnd_Submand_R Glnd_Thyroid GreatVes Heart Hippocampus_L Hippocampus_R Humerus_L Humerus_R Kidney_L Kidney_R Kidneys Larynx Lens_L Lens_R Lips Liver | Bowel Bowel_Extend Bowel_Full Bowel_Superior Bladder Body Body+Mask Bone_Hyoid Bone_Ilium_L Bone_Ilium_R Bone_Ilium Bone_Ischium_L Bone_Ischium_R Bone_Mandible Bone_Pelvic BoneMarrow_Pelvic BrachialPlex_L BrachialPlex_R BrachialPlexs Brain Brainstem Breast_Implant_L Breast_Implant_R Breast_L Breast_R Breasts Bronchus Canal_Anal Carina CaudaEquina Cavity_Oral Cerebellum Chestwall_L Chestwall_R Chestwall Clavicle_L Clavicle_R Cochlea_L Cochlea_R Colon_Sigmoid Cornea_L Cornea_R Duodenum Esophagus Eye_L Eye_R Eyes Femur_Head_L Femur_Head_R Femur_Heads Gallbladder Glnd_Lacrimal_L Glnd_Lacrimal_R Glnd_Submand_L Glnd_Submand_R Glnd_Thyroid GreatVes Heart | | | Item | Limbus Contour v1.8 | Limbus Contour v1.7 - K230575 | Similarities / Differences | | | LN_Ax_Sclav_R LN_Ax_L1_L LN_Ax_L1_R LN_Ax_L2_L LN_Ax_L2_R LN_Ax_L3_L LN_Ax_L3_R LN_Sclav_L LN_Sclav_R LN_IMN_L LN_IMN_R LN_Neck_L LN_Neck_R LN_Neck_234_L LN_Neck_234_R LN_Neck_2347AB_L LN_Neck_2347AB_R LN_Neck_IA LN_Neck_IA6 LN_Neck_IB_L LN_Neck_IB_R LN_Neck_II_L LN_Neck_II_R LN_Neck_III_L LN_Neck_III_R LN_Neck_IV_L LN_Neck_IV_R LN_Neck_V_L LN_Neck_V_R LN_Neck_VI LN_Neck_VIIAB_L LN_Neck_VIIAB_R LN_Pelvis Lung_L Lung_R Lungs Musc_Constrict Musc_PecMinor_L Musc_PecMinor_R Musc_Sclmast_L Musc_Sclmast_R OpticChiasm OpticNrv_L OpticNrv_R Pancreas Parotid_L Parotid_R PelvisVessels PenileBulb Pituitary Prostate Prostate+SeminalVes PubicSymphys Rectum Retina_L Retina_R Ribs_L Ribs_R Ribs | Hippocampus_L Hippocampus_R Humerus_L Humerus_R InternalAuditoryCanal_L InternalAuditoryCanal_R Kidney_L Kidney_R Kidneys Larynx Lens_L Lens_R Lips Liver Lung_L Lung_R Lungs Mesorectum Musc_Constrict Musc_PecMinor_L Musc_PecMinor_R Musc_Sclmast_L Musc_Sclmast_R Optics OpticChiasm OpticNrv_L OpticNrv_R Pancreas Parotid_L Parotid_R PelvisVessels PenileBulb Pericardium Pericardium+A_Pulm Pituitary Prostate Prostate+SeminalVes ProstateBed PubicSymphys Rectum Retina_L Retina_R Ribs_L Ribs_R Ribs Sacrum SeminalVes Skin SpinalCanal SpinalCord Spleen Sternum Stomach Trachea Uterus+Cervix V_Venacava_I V_Venacava_S Vagina VB C1 | | | Item | Limbus Contour v1.8 | Limbus Contour v1.7 - K230575 | Similarities / Differences | | | Sacrum SeminalVes Skin SpinalCanal SpinalCord Spleen Sternum Stomach Trachea Uterus_Cervix V_Venacava_l V_Venacava_S Vagina Ventricle_L MR Structures Brainstem Cornea_L Cornea_R Eye_L Eye_R Hippocampus_L Hippocampus_R Optics PenileBulb Prostate Retina_L Retina_R SeminalVes | VB_C2 VB_C3 VB_C4 VB_C5 VB_C6 VB_C7 VB_L1 VB_L2 VB_L3 VB_L4 VB_L5 VB_T01 VB_T02 VB_T03 VB_T04 VB_T05 VB_T06 VB_T07 VB_T08 VB_T09 VB_T10 VB_T11 VB_T12 VBs Ventricle_L Ventricle_R Bladder_HDR Bowel_HDR Canal_Anal_HDR Colon_Sigmoid_HDR Rectum_HDR Urethra_HDR Bladder_CBCT Femur_Head_L_CBCT Femur_Head_R_CBCT LN_Pelvics_CBCT Prostate_CBCT Rectum_CBCT SeminalVes_CBCT MR Structures Bladder Brainstem Cornea_L Cornea_R Eye_L Eye_R Femur_Head_L Femur_Head_R Hippocampus_L Hippocampus_R Optics PenileBulb PubicSymphys Prostate Rectum Retina_L Retina_R | | | Item | Limbus Contour v1.8 | Limbus Contour v1.7 - K230575…

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