Who is the manufacturer of PeekMed web?

Peek Health, S.A. filed the 510(k) submission for PeekMed web (K240926).

What is the FDA product code for PeekMed web?

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

What is the regulatory pathway for PeekMed web?

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

Does PeekMed web use AI or machine learning?

Yes. PeekMed web (K240926) 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 PeekMed web?

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 PeekMed web 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.

PeekMed web

K240926 · Peek Health, S.A. · LLZ · Dec 6, 2024 · Radiology

Device Facts

Record ID	K240926
Device Name	PeekMed web
Applicant	Peek Health, S.A.
Product Code	LLZ · Radiology
Decision Date	Dec 6, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

PeekMed web is a system designed to help healthcare professionals carry out pre-operative planning for several surgical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the output of the planning. The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers.

Device Story

PeekMed web is a cloud-based medical image management and processing system for orthopedic pre-operative planning. It accepts patient imaging studies (e.g., CT scans) as input. The software uses ML models to perform automated bone segmentation, landmarking, and classification. It allows surgeons to perform 2D/3D planning, including digital overlap and dimensioning of prosthetic templates from a manufacturer database. The system generates a final planning report containing images, measurements, and textual information. Used in clinical environments by healthcare professionals, the output serves as a decision support tool to assist in surgical planning. It does not interact with the patient or provide automated diagnosis; clinical assessment and experience are required for final approval of the plan.

Clinical Evidence

No clinical data. Performance supported by non-clinical bench testing and ML model validation. ML models trained on 2852 CR datasets and 1903 CT scans. External validation performed on 367 unique datasets per model (segmentation, landmarking, classification). Segmentation: DICE >= 90%, HD-95 <= 8, Precision > 85%, Recall > 90%. Landmarking: MRE <= 7mm. Classification: Accuracy, Precision, Recall, F1 >= 90%.

Technological Characteristics

Cloud-based software (SaaS); no local installation required. Operates on web browsers. Utilizes ML models for bone segmentation, landmarking, and classification. Supports 2D/3D image representation, measurement, and prosthetic template overlay. Connectivity requires internet access. Software architecture is a distributed system of communicating server modules.

Indications for Use

Indicated for adult patients with previously diagnosed injury or disability requiring orthopedic pre-surgical planning in the hip, knee, upper limb, or foot regions. Intended for use by qualified healthcare professionals as a decision support tool.

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

PeekMed web (K222767)

Related Devices

K222767 — PeekMed web (v1) · Peek Health, S.A. · Dec 30, 2022
K252452 — PeekMed web · Peek Health, S.A. · Nov 12, 2025
K251096 — PeekMed web · Peek Health, S.A. · Jul 14, 2025
K250042 — PeekMed web · Peek Health, S.A. · Mar 19, 2025
K252856 — PeekMed web · Peek Health, S.A. · Dec 22, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 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 the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Peek Health, S.A. Sara Silva Chief Quality Officer (CQO) Centro de Negócios Ideia Atlântico, Rua Padres Carmelitas Braga, 4719-005 Portugal Re: K240926 December 6, 2024 Trade/Device Name: PeekMed web Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ, QIH Dated: November 1, 2024 Received: November 1, 2024 Dear Sara Silva: 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/cfpm/pm.cfm identifies combination product submissions. The general controls 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" (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). {1}------------------------------------------------ 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-regulatoryinformation/postmarketing-safety-reporting-combination-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 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-advice-comprehensive-regulatory-assistance/unique-deviceidentification-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-reporting-mdr-how-report-medicaldevice-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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/deviceadvice-comprehensive-regulatory-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. Jessica Lamb Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K240926 Device Name PeekMed web Indications for Use (Describe) PeekMed web is a system designed to help healthcare professionals carvy out pre-operative planning for several surgical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the planning. The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------------------------------|--| | <div style="display:flex; align-items:center;"> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | | | <div style="display:flex; align-items:center;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | #### 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 shows the text 'K240926' at the top, followed by a logo in the center. The logo is a stylized, geometric shape in blue, resembling a stylized eye. Below the logo, the text 'PeekMed' is written in a simple, sans-serif font, also in blue. The logo and text likely represent the brand or company named PeekMed. # 510(k) summary / K240926 This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92. #### 1. Submitter Peek Health, S.A. Centro de Negócios Ideia Atlântico Rua Padres Carmelitas 4719-005 Braga Portugal | Contact Person: | Sara Silva | |-----------------|----------------------------------| | | Chief Quality Officer (CQO) | | | Email: sara.silva@peekmed.com | | | Office number: + 351 253 128 941 | Date Summary Prepared: December 5, 2024 #### 2. Device #### 2.1 PeekMed web | Trade Name: | PeekMed web | |-----------------------|------------------------------------------------------------------| | Common or Usual Name: | Medical image management and processing system | | Classification Name: | System, Image Processing, Radiological (21 C.F.R. § 892.2050) | | Regulatory Class: | Class II | | Product Code: | LLZ/QIH | #### 3. Legally Marketed Predicate Device #### 3.1 PeekMed web | 510(k) | Product Name | Clearance Date | |---------|--------------|----------------| | K222767 | PeekMed web | December 2022 | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image features the logo for PeekMed, a medical technology company. The logo consists of a stylized, three-dimensional shape in a teal color, resembling a cube with a section cut out to form a stylized eye. Below the graphic is the company name, "PeekMed," also in teal, presented in a clean, sans-serif typeface. #### 4. Device Description Summary PeekMed web is a system designed to help healthcare professionals carry out pre-operative planning for several surgical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the output of the planning. The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers. As PeekMed web is capable of representing medical images in a 2D or 3D environment, performing relevant measurements on those images, and also capable of adding templates, it then can perform a total overview of the surgery. Being software it does not interact with any part of the body of the user and/or patient. #### 5. Intended Use/Indications for Use PeekMed web is a system designed to help healthcare professionals carry out pre-operative planning for several surqical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the output of the planning. The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers. #### 5.1. Contraindications No contraindications specific to this device. #### 5.2 Indications for Use Comparison There are NO differences between the indications for use of this device and its predicate. #### 6. Technological Comparison to Predicate PeekMed was compared to its respective predicate device in intended use, indications for use, design, function, and technology and it was demonstrated that they are substantially equivalent. Any {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for PeekMed. The logo features a stylized, three-dimensional cube shape in a teal color. Within the cube, there is a white outline of an eye. Below the cube, the word "PeekMed" is written in a simple, sans-serif font, also in teal. technological differences within this 510(k), between the subject device and the predicate device, do not impact substantial equivalence, or safety and effectiveness. The subject device and its predicate are both medical software that allows healthcare professionals to perform orthopedic pre-surgical planning efficiently in the musculoskeletal system of adults in a healthcare environment, therefore sharing the same intended use, and intended patient population. To properly and fully use both devices, clinical judgment, and experience are mandatory. Both devices have the same workflows, use requirements (e.g., internet connection, output validation), and planning features (e.g., model representation, digital overlap of prosthetic material, possible 2D and 3D environments). Both devices generate a final report of the planning which consists of the selected images with templates, measurements, and textual information describing the patient and/or the surgical procedure to be performed. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for PeekMed. The logo is a stylized, geometric shape in blue, resembling a cube or a stylized letter 'P'. Within the shape, there is a white eye symbol, suggesting a focus on vision or medical imaging. Below the shape, the word "PeekMed" is written in a simple, sans-serif font, also in blue. #### Table 1: Summary of Predicate and Subject Device Characteristics to Demonstrate Substantial Equivalence | Characteristic | PeekMed web Predicate device K222767 | PeekMed web Subject device | Substantially Equivalent? | Justification and rationale | |------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | LLZ, QIH | LLZ, QIH | Yes | -- | | Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Yes | -- | | Regulation Name | Medical Image Management And Processing System | Medical Image Management And Processing System | Yes | -- | | Intended use | PeekMed web is a system designed to help healthcare professionals carry out pre-operative planning for several surgical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the output of the planning. The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers. | PeekMed web is a system designed to help healthcare professionals carry out pre-operative planning for several surgical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the output of the planning. The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers. | Yes | -- | | Indications for | This medical device consists of a | This medical device consists of a | Yes | -- | | Characteristic | PeekMed web Predicate device K222767 | PeekMed web Subject device | Substantially Equivalent? | Justification and rationale | | use | decision support tool for qualified healthcare professionals to quickly and efficiently perform the pre-operative planning for several surgical procedures, using medical imaging with the additional capability of planning the 2D or 3D environment. The system is designed for the medical specialties within surgery and no specific use environment is mandatory, whereas the typical use environment is a room with a computer. The patient target group is adult patients who have an injury or disability diagnosed previously. There are no other considerations for the intended patient population. | decision support tool for qualified healthcare professionals to quickly and efficiently perform the pre-operative planning for several surgical procedures, using medical imaging with the additional capability of planning the 2D or 3D environment. The system is designed for the medical specialties within surgery and no specific use environment is mandatory, whereas the typical use environment is a room with a computer. The patient target group is adult patients who have an injury or disability diagnosed previously. There are no other considerations for the intended patient population. | | | | Contraindications | No contraindications specific to this device. | No contraindications specific to this device. | Yes | --- | | Clinical purpose | PeekMed web allows the surgeon to perform orthopedic pre-surgical planning efficiently in the | PeekMed web allows the surgeon to perform orthopedic pre-surgical planning efficiently in the | Yes | --- | | Characteristic | PeekMed web Predicate device K222767 | PeekMed web Subject device | Substantially Equivalent? | Justification and rationale | | | musculoskeletal system (e.g., Hip procedures, Knee procedures) | musculoskeletal system (e.g., Hip procedures, Knee procedures) | | | | Anatomical regions | PeekMed web allows the surgeon to perform the pre-surgical planning efficiently in the following anatomical regions: - Hip - Knee - Upper limb | PeekMed web allows the surgeon to perform the pre-surgical planning efficiently in the following anatomical regions: - Hip - Knee - Upper limb - Foot | Yes The subject device also allows the planning of orthopedic surgery in the foot region. | The subject device allows for the surgery planning on one more anatomical region (foot), this does not constitute a new intended purpose nor does it raise questions of safety and performance, since the development, verification, validation, and release processes are exactly the same between the devices. The new variants of the ML model for foot are considered in this Traditional 510(k) and were developed according to what is defined for each ML model development and validation according to their intended requirements and performance. This change improves the medical device in a way that the user can benefit from the existing features on one more anatomical region. This change does not interfere with or create an effect on other anatomical regions covered by the device. | | Patient Population Adults | | Adults | Yes | --- | | Characteristic | PeekMed web Predicate device K222767 | PeekMed web Subject device | Substantially Equivalent? | Justification and rationale | | End users | Healthcare Professionals | Healthcare Professionals | Yes | --- | | Device availability | Software is cloud-based (not installable) and can be displayed on any personal device or workstation that can run on a web browser | Software is cloud-based (not installable) and can be displayed on any personal device or workstation that can run on a web browser | Yes | --- | | Software Architecture | Distributed system (cloud-based). This distributed system is a combination of software modules placed on servers that are able to communicate with each other. | Distributed system (cloud-based). This distributed system is a combination of software modules placed on servers that are able to communicate with each other. | Yes | --- | | Workflow | The workflow is as follows: Import case images, configure images, identify the case, pre-surgical planning, and export the case. The workflow chart is in Annex 2. | The workflow is as follows: Import case images, configure images, identify the case, pre-surgical planning, and export the case. The workflow chart is in Annex 2. | Yes | --- | | Internet connection | Required | Required | Yes | --- | | Images source | Receives medical images from various sources | Receives medical images from various sources | Yes | --- | | Data processing | The software processes data to provide an overlap and | The software processes data to provide an overlap and | Yes | --- | | Characteristic | PeekMed web Predicate device K222767 | PeekMed web Subject device | Substantially Equivalent? | Justification and rationale | | | dimensioning of digital representations of the prosthetic material | dimensioning of digital representations of the prosthetic material | | | | Digital overlap of templates | Allows the overlap of models and the intersection of the models | Allows the overlap of models and the intersection of the models | Yes | --- | | Interactive model positioning | Yes | Yes | Yes | ---…