Who is the manufacturer of EndoNaut?

Therenva Sas filed the 510(k) submission for EndoNaut (K212383).

What is the FDA product code for EndoNaut?

OWB. It is classified under 21 CFR 892.1650 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for EndoNaut?

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

Does EndoNaut use AI or machine learning?

Yes. EndoNaut (K212383) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for EndoNaut?

EndoNaut (K171829); Cydar Medical's Cydar EV (K160088); EndoSize v3.1 (K160376).

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

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 EndoNaut 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.

EndoNaut

K212383 · Therenva Sas · OWB · Aug 31, 2021 · Radiology

Device Facts

Record ID	K212383
Device Name	EndoNaut
Applicant	Therenva Sas
Product Code	OWB · Radiology
Decision Date	Aug 31, 2021
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1650
Device Class	Class 2
Attributes	AI/ML

Intended Use

EndoNaut provides image guidance by overlaying pre-operative 3D vessel anatomy onto live fluoroscopic images in order to assist in the positioning of the guidewires, catheters and other endovascular devices.

Device Story

EndoNaut is an intraoperative navigation and guidance system for endovascular procedures. It inputs 3D preoperative CT scans (processed via EndoSize software) and live 2D intraoperative fluoroscopy/angiography. The system performs 2D-3D or 2D-2D image registration to overlay preoperative vascular anatomy onto live fluoroscopic images. It assists physicians in positioning guidewires, catheters, and endovascular devices. Used in clinical settings (OR/interventional suite) by physicians. The system includes an 'AI module' for 2D-3D fusion and a 'PAD module' for lower limb panorama creation. Output is displayed on a workstation monitor to guide navigation, potentially improving procedural accuracy and efficiency.

Clinical Evidence

Bench testing only. No clinical data was required or provided. Verification and validation included risk assessment, usability reviews, module verification, integration testing, interoperability testing with EndoSize, and performance/safety testing (electrical, EMC, functional, mechanical) conducted by a COFRAC accredited laboratory.

Technological Characteristics

System consists of EndoNaut Software and an EndoNaut Workstation (TS1CA2DS1-2). Workstation features 27" LCD main display, 15.6" touch screen secondary display, and mobile cart with isolating transformer. Connectivity via Ethernet and USB 3.0. Software is Class II, Moderate level of concern, compliant with IEC 62304, IEC 62366, and ISO 14971. Workstation compliant with IEC 60601-1, ANSI AAMI ES60601-1, IEC 60601-2, and IEC 60601-1-6.

Indications for Use

Indicated for the treatment of patients with endovascular diseases requiring procedures such as endovascular aortic aneurysm repair (AAA and TAA), angioplasty, stenting, and embolization in iliac arteries and corresponding veins. Indicated for endovascular procedures in the thorax, abdomen, pelvis, and lower limbs.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

EndoNaut (K171829)
Cydar Medical's Cydar EV (K160088)
EndoSize v3.1 (K160376)

Related Devices

K222070 — EndoNaut · Therenva Sas · Oct 25, 2022
K171829 — EndoNaut · Therenva Sas · Sep 21, 2017
K243432 — Vascular Navigation PAD 2.0; Navigation Software Vascular PAD · Brainlab AG · Jul 22, 2025
K151598 — VesselNavigator Rel. 1.0 · Philips Medical Systems Nederland B.V. · Aug 17, 2015
K062650 — EP NAVIGATOR SOFTWARE · Philips Medical Systems · Sep 21, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ August 31, 2021 Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue. Therenva SAS % Cemil Göksu CEO 74F rue de Paris Rennes, 35000 FRANCE Re: K212383 Trade/Device Name: EndoNaut Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB Dated: July 12, 2021 Received: August 2, 2021 Dear Cemil Göksu: 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. 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 located 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. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 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-regulatoryassistance/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, Image /page/1/Picture/6 description: The image shows a digital signature. The signature is from Laurel M. Burk -S. The document was signed on August 31, 2021 at 10:53:59 -04'00'. Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K212383 Device Name EndoNaut #### Indications for Use (Describe) EndoNaut is indicated for the treatment of patients with endovascular diseases and who needs, such as but not limited to the following examples: - · endovascular aortic aneurysm repair (AAA and TAA), - · angioplasty, - · stenting. - · embolization in iliac arteries and corresponding veins. EndoNaut is indicated for endovascular procedures in the thorax, abdomen, pelvis and lower limbs. Type of Use (Select one or both, as applicable)X 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." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a logo for a company called "Therenva". The logo consists of a stylized symbol on the left and the company name on the right. The symbol is a teal-colored shape that resembles a sail or a stylized leaf, partially enclosed by a gray circle. The company name "Therenva" is written in gray, with the tagline "Share medical innovation" in a smaller font below the name. # Section 5 - EndoNaut Special 510(K) Summary This Special 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807.92. Therenva SAS hereby submits this Special 510(k) to provide a notification submission for a modified device EndoNaut and evidence of substantial equivalence to to the Predicate Medical Device EndoNaut (K171829). The accessories are also subject to this Special 510(k). #### 1. Submitter information | Manufacturer Name: | Therenva SAS 74F, rue de Paris 35000 Rennes France | |--------------------------------|-------------------------------------------------------------------------------------------------------| | Contact Person: | Mrs Audrey Gallois, OA & RA Leader Phone: +33 6 86 95 44 39 E-mail: audrey.gallois@therenva.com | | Establishment Registration Nº: | 3011240766 | | Date prepared: | 12-Jul-21 | ### 2. Device Identification | Trade Name: | EndoNaut | |----------------------------|----------------------------------------------| | Regulation Name: | Interventional Fluoroscopic X-ray System | | Regulatory Class: | Class II | | Product Code: | OWB | | Classification Regulation: | 21 CFR 892.1650 | | Classification Panel: | Radiology | | Accessories: | 1. Separate interventional tools workstation | | | 2. EndoSize Software | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Therenva. The logo consists of a stylized teal-colored shape resembling a leaf or wing, connected to a gray circle. To the right of the circle is the word "Therenva" in gray, block letters. Below "Therenva" is the tagline "Share medical innovation" in a smaller, lighter gray font. ## 3. Predicate device and accessories - Predicate Medical Device Software: EndoNaut (K171829) ● - Predicate Accessories: - Separate interventional tools workstation, TS1CA2DS1-1 (referred to in K171829 о 510(k) submission) and Cydar Medical's Cydar EV (K160088). - EndoSize v3.1 (K160376) o ### 4. Description of the device EndoNaut system is an imaging solution for intraoperative navigation and guidance tool for endovascular procedures (aorto-iliac and peripheral). EndoNaut provides localization assistance by combining 3D preoperative scans and 2D intra-operative fluoroscopy imagery to help position guides, catheters and other vascular devices. EndoNaut Software is interoperable with EndoSize which is a standalone Software designed and developed by Therenva to enable case planning strategy and device (endoprosthesis) selection before endovascular procedure. EndoSize is used by practitioners (in the preparation phase of the operating procedure) or by endoprosthesis manufacturers to visualize vascular structures and/or carry out an extract of the vascular structure from the preoperative CT scan. EndoSize is intended to be used for pre-operational planning and sizing. EndoSize is medical device software which obtained a substantial equivalence determination and FDA clearance through the CDRH premarket notification process (510(K)) (NºK160376). {5}------------------------------------------------ Image /page/5/Picture/1 description: The image is a logo for Therenva, a company that shares medical innovation. The logo features a stylized symbol on the left, consisting of a teal crescent shape intersecting with a gray circle. To the right of the symbol is the company name, "Therenva," in gray, block letters. Below the name is the tagline, "Share medical innovation," in a smaller, lighter gray font. # 5. Comparison to the cleared (legacy) device and substantial equivalent discussion | Medical Device Software Name | EndoNaut (Predicate Device) K171829 | EndoNaut (Subject Device) | Comparable Properties an Substantial Equivalence Discussion | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Medical Device Software Trade Name | EndoNaut | EndoNaut | Identical | | Accessory 1 | Separate interventional tools workstation | EndoNaut Workstation | Different. Designation adjustment only. We have reclarified the qual- ification of hardware versus software. By definition, here, the hardware (Endo- Naut Workstation) is an ac- cessory to the software med- ical device. To better differ- entiate what is applicable to one and the other, we have identified the software by "EndoNaut Software" and the hardware by "EndoNaut Workstation". The Endo- Naut Workstation alone is not subject to any regulatory submission. It is integrated with the System submitted for FDA approval under the name, EndoNaut. | | Accessory 1 Ref. | TS1CA2DS1-1 | TS1CA2DS1-2 | Different Change of the Panel PC, the Control Panel model and Ca- blings. Due to these changes, the Product number "TS1CA2DS1-2" has been changed. New testings have been performed. | | Accessory 2 | EndoSize Software (K160376) | EndoSize Software (K160376) | Identical EndoSize Software is an ac- cessory that is intended to supplement the performance of EndoNaut. | | Identification and traceability | Name: EndoNaut No UDI | Trade name: EndoNaut Common name: EndoNaut System UDI-DI: 3760262480046 | Different No risk related to idenfica- tion between older and newer EndoNaut device. EndoNaut is now referring to the EndoNaut System while the EndoNaut Software is named EndoNaut Software | | Medical Device Software | EndoNaut | EndoNaut | Comparable Properties an | | Name | (Predicate Device) | (Subject Device) | Substantial | | | K171829 | | Equivalence Discussion | | | | | No unit of the predicate device was sold in the USA. | | Manufacturer | Therenva SAS | Therenva SAS | Identical | | Product Code | OWB | OWB | Identical | | Regulation Number | 892.1650 | 892.1650 | Identical | | Regulation Name | Interventional Fluoroscopic X-Ray System | Interventional Fluoroscopic X-Ray System | Identical | | Software Safety class (62304) | B | B | Identical | | Level of concern | Moderate | Moderate | Identical | | Intended use | Intended use and indications for use were mixed. See below Indications for use. | EndoNaut provides image guidance by overlaying pre- operative 3D vessel anatomy onto live fluoroscopic im- ages in order to assist in the positioning of the guide- wires, catheters and other endovascular devices. | Different A distinction between "In- tended use" and "indications for use" has been made based on the recommendations of the FDA Guidance " The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" (section IV, D, 1). | | Indications for use | EndoNaut provides image guidance by overlaying pre- operative 3D vessel anatomy onto live fluoroscopic im- ages in order to assist in the positioning of the guide- wires, catheters and other endovascular devices. EndoNaut is intended to as- sist endovascular procedures in the thorax, abdomen, neck, pelvis and lower limbs. Suitable procedures include (but not limited to) endovas- cular aortic aneurysm repair (AAA and TAA), angio- plasty, stenting and emboli- zation in iliac arteries and corresponding veins. EndoNaut is not intended for use in the X-ray guided pro- cedures in the liver, kidneys or pelvic organs. | EndoNaut is indicated for the treatment of patients with endovascular diseases and who needs for example (without this list being re- strictive): endovascular aortic an- eurysm repair (AAA and TAA),angioplasty,stenting,embolization in iliac ar- teries and corresponding veins.EndoNaut is indicated for endovascular procedures in the thorax, abdomen, pelvis and lower limbs. | Different A distinction between "In- tended use" and "indications for use" has been made based on the recommendations of the FDA Guidance " The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" (section IV, D, 1). | | Medical Device Software Name | EndoNaut (Predicate Device) K171829 | EndoNaut (Subject Device) | Comparable Properties and Substantial Equivalence Discussion | | Labelling | 1 label in the "about" section for the Medical Device Soft- ware with the Trade Name "EndoNaut" + 1 label for the Separate inter- ventional tools workstation with the Trade Name "Endo- Naut" and Product Number = TS1CA2DS1-1 + unique Serial (production) Number | 1 label in the "about" section for the Medical Device Soft- ware with the Trade Name "EndoNaut Software". + 1 label on the workstation with the Trade Name "Endo- Naut" (for the whole Sys- tem) and Workstation model Number = TS1CA2DS1-2 + unique Serial (production) Number (for the whole Sys- tem) | Different Each component of the En- doNaut System has its proper labelling. Complete review of Label- ling design. Use of symbols of ISO 15223-1. Addition of UDI. Identical The system has a unique identifier (S/N). | | Directions for use (User Guide(s)) | 1 User guide for EndoNaut | 1 User Guide for EndoNaut Software 1 User Guide for EndoNaut Workstation + 1 addendum for informing about the conditions govern- ing the marketing of Endo- Naut. | Different The directions for use have been enhanced to clearly dis- tinguish the instructions spe- cific to the medical device Software, "EndoNaut SW" from the instructions specific to the EndoNaut Work- station, accessory to Endo- Naut SW. | | Hardware compatibility | Software only product; runs on a separate interventional tools (imaging) workstation. | EndoNaut Software is the class II medical device Soft- ware which runs on a sepa- rate interventional tools (im- aging) workstation, the so- named EndoNaut Work- station which is the acces- sory of the medical device software. | Different EndoNaut (legacy device) was intended to be sold with and installed on the separate interventional tools work- station (ref: TS1CA2DS1-1) or installed on any hardware meeting the minimum re- quirements. The conditions for installing the software on the work- station are identical. Only the model number of the workstation has changed (ref: TS1CA2DS1-2). | | Software Operating System | Win Pro 7 SP1x64 Win Pro 10 64bits | Win Pro 10 64bits | Different Support for Windows 7 ended on January 14, 2020. | | Medical Device Software Name | EndoNaut (Predicate Device) K171829 | EndoNaut (Subject Device) | Comparable Properties an Substantial Equivalence Discussion | | Software interoperability | EndoNaut software requires the use of EndoSize software (K160376) to prepare patient data and perform preopera- tive sizing. Data imported from En- doSize include 3D volume, preoperative images, sizing report (comments and meas- urements), and snapshots taken during sizing. | EndoNaut requires the use of EndoSize software (K160376) to prepare patient data and perform preopera- tive sizing. Data imported from En- doSize include 3D volume, preoperative images, sizing report (comments and meas- urements), and snapshots taken during sizing. | Similar Some clarifications are made. Preoperative data is a man- datory input for the use of AI module, but it is not for the PAD module. Preoperative data include pre-op CT images and sizing report (in case of AI module use). The stent placement strategy and sizing are usually per- formed pre-operatively via the use of software devices such as EndoSize. Alternatives to EndoSize ex- ist: other sizing or visualiza- tion software. In such cases, the data is then printed on paper and used in the operat- ing room as is. | | Data management | The user can import and manage patient data within the software. Patient data in- clude pre-op CT images and sizing report. | The user can import and manage patient data within the software. Patient data in- clude pre-op CT images and sizing report. | Similar EndoNaut Software now en- ables import and export of data with a PACS. | | Visualization | Intra-operative fluoroscopy or angiography, pre-opera- tive CT scan image, pre-op- erative 3D scanner volume reconstruction (if any in case of PAD module). AI module only: Before and during the inter- vention, the user can access information from pre-opera- tive sizing report such as pre- op CT images, measure- ments, comments, snap- shots and strategy. | Intra-operative fluoroscopy or angiography, pre-opera- tive CT scan image, pre-op- erative 3D scanner volume reconstruction (if any in case of PAD module). AI module only: Before and during the inter- vention, the user can access information from pre-opera- tive sizing report such as pre- op CT images, measurements, comments, snap- shots and strategy. | Identical | | Export | Take and export snapshots. Export panoramas in case of PAD module. | Take and export snapshots. Export panoramas in case of PAD module. | Identical | | Medical Device Software Name | EndoNaut (Predicate Device) K171829 | EndoNaut (Subject Device) | Comparable Properties an Substantial Equivalence Discussion | | 3D-2D / 2D-2D Registration | AI module: Display 2D-3D fusion: 3D volume pre-op overlay on per-op 2D fluoroscopy. Semi-automatic registration (automatic or manual initial- ization, automatic computa- tion and manual validation). | AI module: Display 2D-3D fusion: 3D volume pre-op overlay on per-op 2D fluoroscopy. Semi-automatic registration (automatic or manual initial- ization, automatic computa- tion and manual validation). | Identical | | | Lower limbs module: Panorama creation: Acquisi- tion and save of fluoroscopy and angiography stage by stage keeping the same C- Arm orientation. Display 2D-2D fusion: 2D pre-op angiographic overlay on per-op 2D fluoroscopy. Synchronization between current per-op 2D fluoros- copy and 2D fluoroscopy from recorded panorama. | PAD (lower limbs) module: Panorama creation: Acquisi- tion and save of fluoroscopy and angiography stage by stage keeping the same C- Arm orientation. Display 2D-2D fusion: 2D pre-op angiographic overlay on per-op 2D fluoroscopy. Synchronization between current per-op 2D fluoros- copy and 2D fluoroscopy from recorded panorama. | | | Dynamic update on C-arm / table / patient motion | Automatic motion detection; registration is updated manually. | Automatic motion detection Registration: auto- matic/manual initialization and manual user validation. | Different Improvement of semi-auto- matic registration (already existing requirement). The change does not significantly affect the use of the device. No new risks or possible er- rors were detected or identi- fied. New clinical data were not necessary. V&V activi- ties were performed and suc- cessful. No additional ques- tions raised for safety and ef- fectiveness. | | Tools | AI module: Draw markers on intra-oper- ative images, locate/track points between per-op and pre-op images, and take measurements on pre-op CT scan images and fusion view. Lower limbs module: Draw lesions markers on panorama (stenosis and | AI module: Draw markers on intra-oper- ative images, locate/track points between per-op and pre-op images, and take measurements on pre-op CT scan images and fusion view. PAD (lower limbs) module: Draw lesions markers on panorama (stenosis and | Identical…