PV-iCurve Pro
Device Facts
| Record ID | K261531 |
|---|---|
| Device Name | PV-iCurve Pro |
| Applicant | Perception Vision Medical Technology Co., Ltd. |
| Product Code | LLZ · Radiology |
| Decision Date | Oct 21, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
PV-iCurve Pro is used by radiation oncology department to contour structures with in medical images in preparation for radiation therapy treatment plans.
Device Story
PV-iCurve Pro is a B/S architecture software system for radiation oncology departments. It imports medical images (CT, CBCT, MR, PET) and RTSTRUCT files via DICOM 3.0. The device provides tools for patient data management, multi-modality image viewing, manual and automatic contouring, image registration (rigid and deformable), and image post-processing. Clinicians use the software to delineate anatomical structures on images to assist in radiation therapy treatment planning. The system outputs contoured structure sets for use in clinical workflows. It operates on Windows 11 platforms.
Clinical Evidence
Bench testing only. Accuracy of rigid and deformable registration algorithms was validated using 30 images each, with Normalized Mutual Information (NMI) metrics exceeding factory thresholds (NMI > 0.4898 for rigid; NMI > 0.8768 for deformable). Auto-contouring accuracy was evaluated on 128 cases (head/neck, chest, abdomen, pelvis) using the Dice Similarity Coefficient (DSC) compared against reference contours; results met factory-set thresholds for all anatomical structures.
Technological Characteristics
B/S architecture software; supports DICOM 3.0 standard. Functions include multi-modality image viewing, manual/automatic contouring, and image registration. Operates on Windows 11 (64-bit). Complies with IEC 62304 for software life cycle processes. Cybersecurity controls implemented per FDA guidance.
Indications for Use
Indicated for use by radiation oncology departments to contour structures in medical images for radiation therapy treatment planning in adult patients.
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
- Velocity (K173636)
Submission Summary (Full Text)
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**U.S. FOOD & DRUG**
ADMINISTRATION
October 21, 2026
Perception Vision Medical Technology Co., Ltd.
Xuling Lu
Regulatory Affairs Director
Rm. 1305, 1306, 1307, 1311, Block B, Zhongda Science And Technology Park,
Bldg. 705, W. District, Yard Garden, # 135, Xingang W. Rd.,
Haizhu District, Guangzhou
China
Re: K261531
Trade/Device Name: PV-iCurve Pro
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: LLZ
Dated: September 24, 2026
Received: September 24, 2026
Dear Xuling Lu:
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 (the 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.
Before making any change significantly affecting the safety or effectiveness of the device, you must submit a new premarket notification in accordance with 21 CFR 807.81. Additional information about changes that
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K261531 - Xuling Lu
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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" (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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K261531 - Xuling Lu
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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,
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
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261531 | ? |
| Please provide the device trade name(s). | | ? |
| PV-iCurve Pro | | |
| Please provide your Indications for Use below. | | ? |
| PV-iCurve Pro is used by radiation oncology department to contour structures with in medical images in preparation for radiation therapy treatment plans. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? |
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K261531
# 510(k) Summary
## Applicant:
| Submitter name: | Perception Vision Medical Technology Co., Ltd. |
| --- | --- |
| Address | Room 1305, 1306, 1307, 1311, Block B, Zhongda Science and Technology Park, Building 705, West District, Yard Garden, No. 135, Xingang West Road, Haizhu District, Guangzhou |
## Official Correspondent:
| Contact Person | Xuling Lu |
| --- | --- |
| Phone | +86 137 9800 9616 |
| E-mail | ra@pvmedtech.com |
## Device Name:
| Device Name | PV-iCurve Pro |
| --- | --- |
| Model Name | PV-iCurve Pro |
| Classification | Class II Device |
| Classification Name | Medical image management and processing system |
| Classification Panel | Medical Device |
| Regulation No. | 892.2050 |
| Products Code | LLZ |
| Medical Specialties | Radiology |
| Predicate Device(s) | Velocity |
| Reason for submission | New Submission |
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## 1. Intended Use
PV-iCurve Pro is used by radiation oncology department to contour structures with in medical images in preparation for radiation therapy treatment plans.
## 2. Purpose Indication for Use
PV-iCurve Pro is used by radiation oncology department to contour structures with in medical images in preparation for radiation therapy treatment plans.
## 3. Device Description
PV-iCurve Pro is developed on B/S architecture, it complies with DICOM 3.0 standard, and it supports processing medical data including CT, CBCT, MR, PET and RTSTRUCT(structure set). PV-iCurve Pro contains tools for patient data management, multi-modality images viewing, structures viewing, manual contouring, automatic contouring, image registration, measurement tools and image post-processing.
## 4. Predicate Device
Predicate Device: Velocity
510(k) No: K173636
## 5. Comparison of the predicate and the subject devices
| Comparison | Subject Device | Predicate Device (K173636) | Comparative results |
| --- | --- | --- | --- |
| Device Name | PV-iCurve Pro | Velocity | / |
| 510(k) No | / | K173636 | / |
| Regulation No. | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Regulation Description | Medical image management and processing system | Picture archiving and communications system | Same |
| Classification Name | System, Image Processing, Radiological | System, Image Processing, Radiological | Same |
| Classification | Class II | Class II | Same |
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| Comparison | Subject Device | Predicate Device (K173636) | Comparative results |
| --- | --- | --- | --- |
| Product code | LLZ | LLZ | Same |
| Indications for Use | PV-iCurve Pro is used by radiation oncology department to contour structures with in medical images in preparation for radiation therapy treatment plans. | Velocity is a software package that provide the physicians a means for comparison of medical data including imaging data that is DICOM. It allows the display, annotation, volume operation, volume rendering, registration, and fusion of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties. Velocity is not intended for mammography. | Both use for anatomy boundary contours. |
| Image Study Importation | Yes, DICOM, Query/Retrieve | Yes DICOM, PET/SPECT/CT/MRI Dose, Query/Retrieve automation added in 4.0 | The subject device doesn't support the PET/SPECT/CT /MRI Dose. |
| Image Structure Import, Save & Export | Yes | Yes | Same |
| Volume rendering | Yes Image 3D rendering | Yes 4D Cine Volume support in 4.0.0 | Both support volume rendering. |
| Advanced Visualization and Navigation Features | Yes | Yes | Same |
| Volume Operations | No | Yes | The subject Device doesn't support. |
| Diagnostic Image registration | Yes | Yes | Same |
| Image Fusion | Yes | Yes | Same |
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| Comparison | Subject Device | Predicate Device (K173636) | Comparative results |
| --- | --- | --- | --- |
| Contouring | Yes | Yes | Same |
| ROI&Contouring | Yes | Yes | Same |
| Manual Contouring Tools | Yes | Yes | Same |
| Image Analysis | No | Yes | The subject Device doesn't support. |
| Plan Review of imported plans or created dose composites | No | Yes | The subject Device doesn't support. |
| Oncology workflow automation | No | Yes | The subject Device doesn't support. |
| Image/ROI Export to DICOM RT | Yes | Yes | Same |
| Secure login and data storage | Yes | Yes | Same |
| Operating System Platform | Windows 11(64bit)24H2 | Microsoft Windows 7 & 10 (64 bit only)/ Windows Server 2008R2 (Citrix), 2012R2, 2016 MAC OS 10.12 Sierra, macOS 10.13 High Sierra | The subject doesn't support MAC OS. The system test was conducted under the Windows operating system and the results passed the test. Additionally, the requirements for the operating system are indicated in the IFU, so this difference does not affect the |
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| Comparison | Subject Device | Predicate Device (K173636) | Comparative results |
| --- | --- | --- | --- |
| | | | safety and effectiveness of the device. |
| Multimodality DICOM Import | | | |
| Import and display DICOM CT, MR, DS, PET, RTS, RTP | Yes Supports DICOM CT、MR、PET、RTS | Yes | The subject device doesn't support DS, RPT. |
| Advanced Visualization & Navigation | | | |
| General image viewer with view layout selection and toolbars | Yes | Yes | Same |
| Volume Operations | | | |
| User scaling of image volumes | No | No | The subject Device doesn't support. |
| Biological Effective Dose (BED) Scaling | No | No | The subject Device doesn't support. |
| Y-90 Microsphere Dosimetry –conversion of SPECT to DS | No | No | The subject Device doesn't support. |
| Automated Image-based Registration | | | |
| Manual registration editing | Yes | Yes | Same |
| Auto Rigid Registration | Yes | Yes | Same |
| Deformable Registration | Yes | Yes | Same |
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| Comparison | Subject Device | Predicate Device (K173636) | Comparative results |
| --- | --- | --- | --- |
| Inverse deformable registration | No | Yes | The subject Device doesn't support. |
| Structure Guided deformable | No | Yes | The subject Device doesn't support. |
| Segmentation (Manual Contouring Tools and Atlas Segmentation) | | | |
| Manual Contouring tools | Yes | Yes | Same |
| Atlas Auto-Segmentation | Yes | Yes | Same |
| Image analysis with volumetric graphs | | | |
| Histograms and Voxel Assessment graphs | No | Yes | The subject Device doesn't support. |
| DVH statistics display | No | Yes | The subject Device doesn't support. |
| Plan review | | | |
| Storage and display of DICOM RT Plans | No | Yes | The subject Device doesn't support. |
| Lesion volume tracking by associating structure with name tag | No | Yes | The subject Device doesn't support. |
| Navigator Semi-Automated Workflows | | | |
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| Comparison | Subject Device | Predicate Device (K173636) | Comparative results |
| --- | --- | --- | --- |
| Semi-automatic workflows to assist with common clinical image registration & analysis tasks | No | Yes | The subject Device doesn't support. |
| Adaptive Navigators to assist in offline dose review: includes workflows to create adaptive CT based on CBCT registration, copy plan to adaptive CT, and compare dose. | No | Yes | The subject Device doesn't support. |
| Security | | | |
| Logging of database activity | Yes | Yes | Same |
The features table lists the features of PV-iCurve Pro, as compared to the predicate device, Velocity (K173636), the PV-iCurve Pro is similar in characteristics, features and indications for use as the predicates, it is substantially equivalent to the predicate device. And it does not pose any new issues of safety and effectiveness.
## 6. Performance Data
The following performance data were provided in support the substantial equivalence determination.
### Software Verification and Validation Testing
Software verification and validation testing were conducted and documented per FDA guidance, "Content of Premarket Submissions for Device Software Functions".
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Verification according to the applicable safety and performance standards was conducted as IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes.
## Cybersecurity
Cybersecurity test was conducted and documented per FDA guidance, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions".
## Summary of Non-Clinical Trial
### Auto Rigid Registration:
In order to verify the accuracy of rigid registration, a total of 30 images from the United States, Europe and China were selected. The normalized mutual information between the fixed image F and the registered image result N was calculated to test the accuracy of the rigid registration algorithm for different human bodies. The acceptance criterion for the rigid registration algorithm is that the NMI index of the rigid registration should be greater than 0.4898. The test records are presented in the table below. The results showed that the rigid registration algorithm reached the factory threshold and met the clinical evaluation standards.
| Parts | Modality | patient_id | Data format | Normalized Mutual Information (NMI) |
| --- | --- | --- | --- | --- |
| Head and neck | CBCT2CT | 38423 | dcm | 1.0662 |
| | | 41793 | dcm | 1.0825 |
| | | 254793 | dcm | 1.0675 |
| | | 304670 | dcm | 1.0676 |
| | | 305621 | dcm | 1.0812 |
| | MR2CT | 8439852 | dcm | 1.0385 |
| | | 8571440 | dcm | 1.0285 |
| | | 8584084 | dcm | 1.0731 |
| | | case_31 | dcm | 1.1227 |
| Chest | CBCT2CT | 11126 | dcm | 1.1593 |
| | | 18159 | dcm | 1.1193 |
| | | 62973 | dcm | 1.0811 |
| | | 267679 | dcm | 1.1239 |
| | | 277567 | dcm | 1.2821 |
| | | 100_HM10395 | dcm | 1.1019 |
| | MR2CT | 990592 | dcm | 1.2112 |
| | CT2CT | 129967 | dcm | 1.0441 |
| | | 141439 | dcm | 1.0759 |
| | | 142116 | dcm | 1.0741 |
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| Abdomen and pelvis | CBCT2CT | 354094 | dcm | 1.0615 |
| --- | --- | --- | --- | --- |
| | | 658940 | dcm | 1.0613 |
| | | 1414949 | dcm | 1.1194 |
| | | 1437921 | dcm | 1.0735 |
| | | 1442291 | dcm | 1.1086 |
| | | Pancreas-CT-CB_004 | dcm | 1.1539 |
| | MR2CT | 99753 | dcm | 1.1045 |
| | | 911671 | dcm | 1.2668 |
| | | 471748 | dcm | 1.0534 |
| | | 1_03_P | dcm | 1.0691 |
| | CT2CT | 996662 | dcm | 1.0700 |
### Deformable Registration:
In order to verify the accuracy of deformable registration, a total of 30 images from the United States, Europe and China were selected. The normalized mutual information between the fixed image F and the registered image result N was calculated to test the accuracy of the rigid registration algorithm for different human bodies. If NMI>0.8768, it is considered that the fixed image is registered with the resulting image N. The test records are presented in the table below. The results showed that the rigid registration algorithm reached the factory threshold and met the clinical evaluation standards.
| Parts | Modality | patient_id | Data format | Normalized Mutual Information (NMI) |
| --- | --- | --- | --- | --- |
| Head and neck | CBCT2CT | 38423 | dcm | 1.0713 |
| | | 41793 | dcm | 1.0840 |
| | | 254793 | dcm | 1.0690 |
| | | 304670 | dcm | 1.0713 |
| | | 305621 | dcm | 1.0863 |
| | MR2CT | 8439852 | dcm | 1.0426 |
| | | 8571440 | dcm | 1.0324 |
| | | 8584084 | dcm | 1.0804 |
| | | case_31 | dcm | 1.1314 |
| Chest | CBCT2CT | 11126 | dcm | 1.1715 |
| | | 18159 | dcm | 1.1319 |
| | | 62973 | dcm | 1.0898 |
| | | 267679 | dcm | 1.1413 |
| | | 277567 | dcm | 1.3383 |
| | | 100_HM10395 | dcm | 1.1127 |
| | MR2CT | 990592 | dcm | 1.2219 |
| | CT2CT | 129967 | dcm | 1.0800 |
| | | 141439 | dcm | 1.0838 |
| | | 142116 | dcm | 1.0792 |
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| Abdomen and pelvis | CBCT2CT | 354094 | dcm | 1.0645 |
| --- | --- | --- | --- | --- |
| | | 658940 | dcm | 1.0678 |
| | | 1414949 | dcm | 1.1279 |
| | | 1437921 | dcm | 1.1236 |
| | | 1442291 | dcm | 1.1228 |
| | | Pancreas-CT-CB_004 | dcm | 1.2188 |
| | MR2CT | 99753 | dcm | 1.1613 |
| | | 911671 | dcm | 1.2709 |
| | | 471748 | dcm | 1.0569 |
| | | 1_03_P | dcm | 1.0773 |
| | CT2CT | 996662 | dcm | 1.0826 |
### Auto Contouring:
Images were selected from public datasets in the United States and Europe, including 35 cases of head and neck, 30 cases of chest, 30 cases of abdomen, and 33 cases of pelvis, totaling 128 test cases. The accuracy of the automatic outlining algorithm was evaluated by calculating the Dice coefficient (DSC) value, which measures the overlap between the contours of human organs and reference contours. The reference contours were either pre-existing outlines from public databases or results drawn by experienced radiologists. The Acceptance Criterion and test records are presented in the table below. The results indicated that all automatic outlining algorithms met the factory-set thresholds and satisfied clinical evaluation standards.
| Body Parts | Name | AC | dice |
| --- | --- | --- | --- |
| Head and neck | Body | 0.8 | 0.9954 |
| | BrachialPlex_L | 0.6 | 0.6369 |
| | BrachialPlex_R | 0.6 | 0.6456 |
| | Brain | 0.8 | 0.9863 |
| | Brainstem | 0.8 | 0.8072 |
| | Cerebellum | 0.8 | 0.9713 |
| | Cerebrum | 0.8 | 0.9799 |
| | Chiasm | 0.6 | 0.6788 |
| | Chiasm_1 | 0.6 | 0.6326 |
| | Cochlea_L | 0.6 | 0.7497 |
| | Cochlea_R | 0.6 | 0.7261 |
| | Esophagus | 0.8 | 0.8527 |
| | ETbone_L | 0.6 | 0.8038 |
| | ETbone_R | 0.6 | 0.7163 |
| | Eye_L | 0.8 | 0.9021 |
| | Eye_L_1 | 0.8 | 0.9021 |
| | Eye_R | 0.8 | 0.9037 |
| | Eye_R_1 | 0.8 | 0.9037 |
| | Eye_Ant_L | 0.7 | 0.7972 |
| | Eye_Ant_R | 0.7 | 0.8203 |
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| | Eye_Post_L | 0.8 | 0.9292 |
| --- | --- | --- | --- |
| | Eye_Post_R | 0.8 | 0.9313 |
| | Glnd_Lacrimal_L | 0.6 | 0.6200 |
| | Glnd_Lacrimal_R | 0.6 | 0.6225 |
| | Hippocampus_L | 0.6 | 0.8221 |
| | Hippocampus_R | 0.6 | 0.8183 |
| | IAC_L | 0.6 | 0.8096 |
| | IAC_R | 0.6 | 0.7918 |
| | Larynx | 0.6 | 0.8835 |
| | Larynx_Glottic | 0.6 | 0.7932 |
| | Larynx_Supraglottic | 0.6 | 0.7222 |
| | Lens_L | 0.6 | 0.8148 |
| | Lens_L_1 | 0.6 | 0.8148 |
| | Lens_R | 0.6 | 0.8156 |
| | Lens_R_1 | 0.6 | 0.8156 |
| | Mandible | 0.8 | 0.8717 |
| | Mandible_L | 0.8 | 0.8807 |
| | Mandible_R | 0.8 | 0.8738 |
| | Mastoid_L | 0.7 | 0.9442 |
| | Mastoid_R | 0.7 | 0.9175 |
| | MiddleEar_L | 0.7 | 0.8689 |
| | MiddleEar_R | 0.7 | 0.8468 |
| | OpticNerve_L | 0.6 | 0.7742 |
| | OpticNerve_L_1 | 0.7 | 0.7457 |
| | OpticNerve_R | 0.6 | 0.7928 |
| | OpticNerve_R_1 | 0.7 | 0.7636 |
| | OralCavity | 0.8 | 0.9313 |
| | OralCavity_1 | 0.8 | 0.9424 |
| | Parotid_L | 0.7 | 0.7811 |
| | Parotid_L_1 | 0.8 | 0.8918 |
| | Parotid_R | 0.7 | 0.7655 |
| | Parotid_R_1 | 0.8 | 0.9049 |
| | PharynxConst_I | 0.6 | 0.7566 |
| | PharynxConst_M | 0.6 | 0.7698 |
| | PharynxConst_S | 0.6 | 0.8366 |
| | Pituitary | 0.6 | 0.8088 |
| | Skull | 0.7 | 0.816 |
| | SpinalCanal | 0.8 | 0.9456 |
| | SpinalCord | 0.8 | 0.9054 |
| | Submandibular_L | 0.7 | 0.7698 |
| | Submandibular_R | 0.7 | 0.7556 |
| | TemporalLobe_L | 0.8 | 0.9479 |
| | TemporalLobe_L_1 | 0.8 | 0.9282 |
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| | TemporalLobe_R | 0.8 | 0.9494 |
| --- | --- | --- | --- |
| | TemporalLobe_R_1 | 0.8 | 0.9434 |
| | TMjoint_L | 0.7 | 0.9026 |
| | TMjoint_R | 0.7 | 0.8864 |
| | Trachea | 0.7 | 0.9059 |
| | TympanicCavity_L | 0.6 | 0.8144 |
| | TympanicCavity_R | 0.6 | 0.7995 |
| | Vertebrae | 0.8 | 0.9290 |
| | VestibulSemi_L | 0.6 | 0.7844 |
| | VestibulSemi_R | 0.6 | 0.7364 |
| | LN_Neck_L | 0.7 | 0.8153 |
| | LN_Neck_R | 0.7 | 0.8456 |
| | LN_Neck_VI | 0.7 | 0.7658 |
| | LN_Neck_IB_L | 0.7 | 0.8206 |
| | LN_Neck_IB_R | 0.7 | 0.8191 |
| | LN_Neck_II_L | 0.7 | 0.8906 |
| | LN_Neck_II_R | 0.7 | 0.8959 |
| | LN_Neck_III_L | 0.7 | 0.8662 |
| | LN_Neck_III_R | 0.7 | 0.8590 |
| | LN_Neck_IVA_L | 0.7 | 0.8116 |
| | LN_Neck_IVA_R | 0.7 | 0.7889 |
| | LN_Neck_IVB_L | 0.7 | 0.8084 |
| | LN_Neck_IVB_R | 0.7 | 0.7825 |
| | LN_Neck_VA_L | 0.7 | 0.8181 |
| | LN_Neck_VA_R | 0.7 | 0.8023 |
| | LN_Neck_VB_L | 0.7 | 0.7355 |
| | LN_Neck_VB_R | 0.7 | 0.7247 |
| | LN_Neck_VC_L | 0.7 | 0.7454 |
| | LN_Neck_VC_R | 0.7 | 0.7339 |
| | LN_Neck_VIA | 0.7 | 0.8056 |
| | LN_Neck_VIB | 0.7 | 0.7459 |
| | LN_Neck_VII_L | 0.7 | 0.7632 |
| | LN_Neck_VII_R | 0.7 | 0.8005 |
| | LN_Neck_Xa_L | 0.7 | 0.7223 |
| | LN_Neck_Xa_R | 0.7 | 0.7668 |
| | LN_Neck_Xb_L | 0.6 | 0.6103 |
| LN_Neck_Xb_R | 0.6 | 0.6216 | |
| Chest | Body | 0.8 | 0.9907 |
| | Aorta | 0.8 | 0.8354 |
| | Ascending_aorta | 0.9 | 0.9342 |
| | Descending_aorta | 0.9 | 0.9558 |
| | Atrium_L | 0.8 | 0.8766 |
| | Atrium_R | 0.8 | 0.8905 |
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{17}
| | Pericardium | 0.9 | 0.9718 |
| --- | --- | --- | --- |
| | Ventricle_L | 0.8 | 0.9225 |
| | Ventricle_R | 0.8 | 0.8992 |
| | LAD | 0.9 | 0.9406 |
| | RCA | 0.9 | 0.9490 |
| | Bone_Chest | 0.9 | 0.9210 |
| | Breast | 0.8 | 0.8500 |
| | Breast_L | 0.8 | 0.9018 |
| | Breast_L_2 | 0.8 | 0.8610 |
| | Breast_R | 0.8 | 0.8782 |
| | Breast_R_2 | 0.8 | 0.8420 |
| | BronchialTree | 0.7 | 0.8242 |
| | ChestWall | 0.9 | 0.9493 |
| | Clavicula | 0.9 | 0.9600 |
| | Esophagus | 0.7 | 0.7516 |
| | Heart | 0.8 | 0.9755 |
| | Heart_1 | 0.9 | 0.9777 |
| | HumerusHead | 0.8 | 0.8100 |
| | HumerusHead_L | 0.8 | 0.817 |
| | HumerusHead_R | 0.8 | 0.8442 |
| | HumerusHead_1 | 0.9 | 0.9380 |
| | HumerusHead_L_1 | 0.9 | 0.9397 |
| | HumerusHead_R_1 | 0.9 | 0.9364 |
| | Lungs | 0.9 | 0.9312 |
| | Lung_L | 0.8 | 0.9323 |
| | Lung_R | 0.8 | 0.9365 |
| | Ribs | 0.8 | 0.904 |
| | Scapula | 0.9 | 0.9540 |
| | SpinalCanal | 0.8 | 0.9456 |
| | SpinalCord | 0.7 | 0.7643 |
| | Sternum | 0.8 | 0.9060 |
| | Thyroid | 0.7 | 0.8369 |
| | Thyroid_L | 0.7 | 0.8310 |
| | Thyroid_R | 0.7 | 0.8290 |
| | Trachea | 0.7 | 0.7753 |
| | Vertebrae | 0.9 | 0.9290 |
| | LN_IMN_L | 0.7 | 0.7071 |
| | LN_IMN_R | 0.7 | 0.7290 |
| | LN_Clavicle_L | 0.7 | 0.8685 |
| | LN_Clavicle_R | 0.7 | 0.8689 |
| | LN_Ax_I_L | 0.7 | 0.8511 |
| | LN_Ax_I_R | 0.7 | 0.8268 |
| | LN_Ax_II_L | 0.7 | 0.8416 |
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{18}
| | LN_Ax_II_R | 0.7 | 0.8311 |
| --- | --- | --- | --- |
| | LN_Ax_III_L | 0.7 | 0.7695 |
| | LN_Ax_III_R | 0.7 | 0.7635 |
| | LN_MD_1L | 0.6 | 0.6980 |
| | LN_MD_1R | 0.6 | 0.6980 |
| | LN_MD_2L | 0.6 | 0.7650 |
| | LN_MD_2R | 0.6 | 0.7410 |
| | LN_MD_3A | 0.6 | 0.7700 |
| | LN_MD_3P | 0.6 | 0.6510 |
| | LN_MD_4L | 0.6 | 0.7350 |
| | LN_MD_4R | 0.6 | 0.7630 |
| | LN_MD_5 | 0.6 | 0.7240 |
| | LN_MD_6 | 0.6 | 0.6930 |
| | LN_MD_7 | 0.6 | 0.6820 |
| | LN_MD_8 | 0.6 | 0.7030 |
| | LN_MD_10L | 0.6 | 0.6970 |
| | LN_MD_10R | 0.6 | 0.6350 |
| Abdomen | Body | 0.8 | 0.9954 |
| | Kidney | 0.8 | 0.8500 |
| | Kidney_L | 0.8 | 0.8579 |
| | Kidney_R | 0.8 | 0.8525 |
| | Liver | 0.8 | 0.9241 |
| | Liver_1 | 0.8 | 0.9352 |
| | Pancreas | 0.8 | 0.8148 |
| | SpinalCanal | 0.8 | 0.9456 |
| | SpinalCord | 0.8 | 0.7826 |
| | Spleen | 0.8 | 0.9311 |
| | Stomach | 0.8 | 0.9191 |
| | Vertebrae | 0.8 | 0.9290 |
| Pelvis | Body | 0.8 | 0.9926 |
| | Analcanal | 0.7 | 0.7254 |
| | Anorectum | 0.7 | 0.8265 |
| | Bladder | 0.8 | 0.9157 |
| | Bone_Ilium_L | 0.8 | 0.9697 |
| | Bone_Ilium_R | 0.8 | 0.9697 |
| | Bone_Ischium_L | 0.8 | 0.9587 |
| | Bone_Ischium_R | 0.8 | 0.9539 |
| | BowelBag | 0.8 | 0.9661 |
| | Colon | 0.8 | 0.886 |
| | Duodenum | 0.7 | 0.7874 |
| | FemoralHead | 0.8 | 0.9316 |
| | FemoralHead_L | 0.8 | 0.9318 |
| | FemoralHead_R | 0.8 | 0.9332 |
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{19}
| | FemoralJoint | 0.8 | 0.8492 |
| --- | --- | --- | --- |
| | FemoralJoint_L | 0.8 | 0.8591 |
| | FemoralJoint_R | 0.8 | 0.8365 |
| | PelvicBone | 0.8 | 0.9129 |
| | PelvicBoneMarrow | 0.8 | 0.8841 |
| | PenileBulb | 0.7 | 0.7337 |
| | Prostate | 0.7 | 0.9174 |
| | ProstateSeminalVes | 0.7 | 0.7134 |
| | PubicSymphys | 0.8 | 0.9553 |
| | Rectum | 0.7 | 0.9254 |
| | Sigmoid | 0.6 | 0.9009 |
| | SmallBowel | 0.7 | 0.8411 |
| | SpinalCord | 0.7 | 0.7799 |
| | SpinalCord_1 | 0.7 | 0.8056 |
| | SpinalCanal | 0.7 | 0.8443 |
| | Uterus | 0.8 | 0.8909 |
| | Vertebrae | 0.8 | 0.9290 |
| | LN_CommonIliac | 0.7 | 0.7904 |
| | LN_ExternalIliac | 0.7 | 0.7907 |
| | LN_InternalIliac | 0.7 | 0.7819 |
| | LN_Inguinal | 0.7 | 0.8466 |
| | LN_IschiorestalFossa | 0.7 | 0.8658 |
| | LN_PAA | 0.7 | 0.8506 |
| | LN_Obturator | 0.7 | 0.7688 |
| | LN_PresacralSpace_A | 0.6 | 0.6915 |
| | LN_PresacralSpace_B | 0.6 | 0.7538 |
| | LN_Mesorectum | 0.7 | 0.8401 |
## 7. Conclusion
The information included in this submission demonstrates that the PV-iCurve Pro is substantially equivalent to the predicate device (K173636). Although there are minor differences noted between the proposed system and the predicate device, these differences do not raise significant new questions of safety or effectiveness.
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