Who is the manufacturer of 3mensio Workstation?

Pie Medical Imaging BV filed the 510(k) submission for 3mensio Workstation (K153736).

What is the FDA product code for 3mensio Workstation?

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

What is the regulatory pathway for 3mensio Workstation?

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

What are the predicate devices for 3mensio Workstation?

3mensio Workstation (K120367); Philips Intellispace Cardiovascular (K153022).

Who can help prepare an FDA 510(k) submission like 3mensio Workstation?

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.

3mensio Workstation

K153736 · Pie Medical Imaging BV · LLZ · May 27, 2016 · Radiology

Device Facts

Record ID	K153736
Device Name	3mensio Workstation
Applicant	Pie Medical Imaging BV
Product Code	LLZ · Radiology
Decision Date	May 27, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

3mensio Workstation is a software solution that is intended to provide Cardiologists, Radiologists and Clinical Specialists additional information to aid them in reading and interpreting DICOM compliant medical images of structures of the heart and vessels. 3mensio Structural Heart enables the user to: Visualize and measure (diameters, lengths, areas, volumes, angles) structures of the heart and vessels Quantify calcium (volume, density) 3mensio Vascular enables the user to: Visualize and assess stenosis, aneurisms and vascular structures Measure the dimensions of vessels (diameters, lengths, areas, volumes, angles)

Device Story

3mensio Workstation is a software-based medical imaging tool for cardiologists, radiologists, and clinical specialists. It ingests DICOM-compliant medical images (CT, MRI, XA, etc.) from various data sources and networks. The software performs segmentation of cardiovascular structures and automatic/manual centerline detection to generate 3D models from 2D scan slices. It provides visualization techniques including Volume Rendering, MPR, Curved MPR, and MIP. Users interact with the workstation to perform measurements (diameters, lengths, volumes, angles) and calcium scoring. The output—visualizations, measurements, and reports—is used by clinicians to aid in pre-operative planning, sizing for cardiovascular interventions, and postoperative evaluation. By quantifying coronary artery dimensions and calcifications, the device supports clinical diagnosis and procedural preparation, potentially improving the accuracy and reliability of cardiovascular surgical planning.

Clinical Evidence

Bench testing only. Verification and validation performed according to Design Control procedures. System requirements were verified to be implemented correctly. A test report comparing numerical results of the subject device against predicate devices was generated to demonstrate effectiveness.

Technological Characteristics

Software-based image processing system running on Microsoft Windows. Supports DICOM-compliant datasets (CT, MRI, XA, etc.). Features include segmentation, centerline detection, and various 3D reconstruction techniques (MPR, MIP, Volume Rendering). Connectivity via standard network protocols. Conforms to NEMA PS 3.1-3.20 (DICOM) and ISO 14971 (risk management).

Indications for Use

Indicated for visualization and measurement of heart and vessel structures for pre-operational planning/sizing for cardiovascular interventions/surgery, postoperative evaluation, and support of clinical diagnosis by quantifying coronary artery dimensions and calcifications (calcium scoring).

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

3mensio Workstation (K120367)
Philips Intellispace Cardiovascular (K153022)

Related Devices

K120367 — 3MENSIO WORKSTATION · Pie Medical Imaging BV · Apr 17, 2012
K250330 — 3mensio Workstation · Pie Medical Imaging BV · Nov 3, 2025
K220727 — inHEART MODELS · Inheart, Sas · May 10, 2022
K191585 — iNtuition-Structural Heart Module · Terarecon,Inc. · Jul 12, 2019
K190874 — Materialise Mimics Enlight · Materialise NV · Jun 5, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 27, 2016 Pie Medical Imaging B.V. % Ms. Annemeik Bouts Regulatory Affairs Coordinator Philipsweg 1 Maastricht 6227 AJ THE NETHERLANDS Re: K153736 Trade/Device Name: 3mensio Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 20, 2016 Received: May 2, 2016 Dear Ms. Bouts: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Robert Ochs Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K153736 Device Name 3mensio Workstation Indications for Use (Describe) 3mensio Workstation enables visualization and measurement of the heart and vessels for: - · Pre-operational planning and sizing for cardiovascular interventions and surgery - · Postoperative evaluation - · Support of clinical diagnosis by quantifying dimensions in coronary arteries - · Support of clinical diagnosis by quantifying calcifications (calcium scoring) in the coronary arteries To facilitate the above, the 3mensio Workstation provides general functionality such as: - · Segmentation of cardiovascular structures - · Automatic and manual centerline detection · Visualization and image reconstruction techniques: 2D review, Volume Rendering, MPR, Curved MPR, Stretched - CMPR, Slabbing, MIP, AIP, MinIP · Measurement and annotation tools - Reporting tools 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}------------------------------------------------ | 510(k) Summary | 3mensio Workstation 8.0 | [GEN2261]v1.0 | |---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | Submitter/Owner Name | Pie Medical Imaging BV | | | Address | Philipsweg 1, 6227 AJ Maastricht, The Netherlands | | | Phone Number | +31 43 32 81 328 | | | Fax Number | +31 43 32 81 329 | | | Contact Person: | Annemiek Bouts, Regulatory Affairs Coordinator | | | Email Address | annemiek.bouts@pie.nl | | | Preparation Date | 16-dec-15 | | | Trade Name | 3mensio Structural Heart / 3mensio Vascular | | | Common Name | 3mensio Workstation | | | Classification: | Classification Name: Image Processing System Classification Panel: Radiology Regulation Class: Class II Regulation number: 21 CFR 892.2050 Classification Product Code: LLZ | | | Predicate Devices | 3mensio Workstation (K120367) Philips Intellispace Cardiovascular (K153022) | | | Device Description | The 3mensio Workstation software allows cardiologists, radiologist and clinical specialists to select patient studies from various data sources, view them, and process the images with the help of a comprehensive set of tools. 3mensio Workstation works with all major medical image formats and can access multiple data stores and across networks. 3mensio Workstation can combine 2D scan slices into comprehensive 3D models of the patient, and can display supporting ultrasound and X-ray Angio data. The software accurately represents different types of tissue, making it easier to diagnose anomalies in scans. 3mensio Workstation contains two modules, 3mensio Structural Heart (containing submodule cCTA), and 3mensio Vascular which can be marketed in combination or as separate solutions: 3mensio Structural Heart enables assessment and measurement of differen structures of the heart, e.g. aortic valve, mitral valve and ventricles. It provides analysis of the feasibility of a transapical, transfemoral or subclavian approach to structures for replacement or repair procedures. 3mensio cCTA enables assessment and measurement of the coronary arteries and can help in the quantification of the dimensions of the coronary arteries and of the calcified plaques present in coronary arteries. 3mensio Vascular enables assessment of vessels and can help identify calcifications, aneurysms and other anomalies to quickly and reliably prepare for various types of vascular procedures. | | | The results can be displayed, printed or saved in a variety of formats to a hard disk, network, PACS system or CD. Results can also be printed as a hardcopy. | | | | Intended Use | 3mensio Workstation is a software solution that is intended to provide Cardiologists, Radiologists and Clinical Specialists additional information to aid them in reading and interpreting DICOM compliant medical images of structures of the heart and vessels. 3mensio Structural Heart enables the user to: Visualize and measure (diameters, lengths, areas, volumes, angles) structures of the heart and vessels Quantify calcium (volume, density) 3mensio Vascular enables the user to: Visualize and assess stenosis, aneurisms and vascular structures Measure the dimensions of vessels (diameters, lengths, areas, volumes, angles) | | | Indications for Use | 3mensio Workstation enables visualization and measurement of structures of the heart and vessels for: Pre-operational planning and sizing for cardiovascular interventions and surgery Postoperative evaluation Support of clinical diagnosis by quantifying dimensions in coronary arteries Support of clinical diagnosis by quantifying calcifications (calcium scoring) in the coronary arteries To facilitate the above, the 3mensio Workstation provides general functionality such as: Segmentation of cardiovascular structures Automatic and manual centerline detection | | {4}------------------------------------------------ - Measurement and annotation tools ● - . Reporting tools Technological Characteristics Comparison A comparison of the technological characteristics of the predicate and subject device is given the table below. #### New Device Predicate Device Predicate Device 3mensio Workstation Device name 3mensio Workstation Intellispace Cardiovascular Pie Medical Imaging Manufacturer Pie Medical Imaging Philips K120367 510(k) number K153022 Intended Use and Indications for Use Intended use 3mensio Workstation is a software 3mensio Workstation is a software Philips IntelliSpace Cardiovascular solution that is intended to provide solution that is intended to provide software product is an integrated cardiologists, radiologists and clinical cardiologists, radiologists and clinical multimodality image and information specialists additional information to aid specialists additional information to aid system designed to perform the them in reading and interpreting them in reading and interpreting DICOM necessary functions required for DICOM compliant medical images of compliant medical images of structures of import, export, storage, archival, structures of the heart and vessels. the heart and vessels. review, analysis, quantification, reporting and database management 3mensio Structural Heart enables the 3mensio Structural Heart enables the user of digital medical images. user to: to: · Visualize and measure (diameters, · Visualize and measure (diameters, lengths, areas, volumes, angles) lengths, areas, volumes, angles) structures of the heart and vessels structures of the heart and vessels · Quantify calcium (volume, density) · Quantify calcium (volume, density) 3mensio Vascular enables the user to: 3mensio Vascular enables the user to: · Visualize and assess stenosis, · Visualize and assess stenosis, aneurisms aneurisms and vascular structures and vascular structures · Measure the dimensions of vessels · Measure the dimensions of vessels (diameters, lengths, areas, volumes, (diameters, lengths, areas, volumes, {5}------------------------------------------------ | | New Device | Predicate Device | Predicate Device | |-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name | 3mensio Workstation | 3mensio Workstation | Intellispace Cardiovascular | | Manufacturer | Pie Medical Imaging | Pie Medical Imaging | Philips | | 510(k) number | - | K120367 | K153022 | | | angles) | angles) | | | Indications for Use | 3mensio Workstation enables visualization and measurement of structures of the heart and vessels for: • Pre-operational planning and sizing for cardiovascular interventions and surgery • Postoperative evaluation • Support of clinical diagnosis by quantifying dimensions in coronary arteries • Support of clinical diagnosis by quantifying calcified plaques (calcium scoring) in the coronary arteries To facilitate the above, the 3mensio Workstation provides general functionality such as: • Segmentation of cardiovascular structures • Automatic and manual centerline detection • Visualization and image reconstruction techniques: 2D review, Volume Rendering, MPR, Curved MPR, Stretched CMRP, Slabbing, MIP, AIP, MinIP • Measurement and annotation tools • Reporting tools | 3mensio Workstation enables visualization and measurement of structures of the heart and vessels for: • Pre-operational planning and sizing for cardiovascular interventions and surgery • Postoperative evaluation To facilitate the above, the 3mensio Workstation provides general functionality such as: • Segmentation of cardiovascular structures • Automatic and manual centerline detection • Visualization and image reconstruction techniques: 2D review, Volume Rendering, MPR, Curved MPR, Stretched CMRP, Slabbing, MIP, AIP, MinIP • Measurement and annotation tools • Reporting tools | Philips IntelliSpace Cardiovascular software product is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images, waveforms and data related to cardiology. Philips IntelliSpace Cardiovascular offers support for third party applications in order to enable the use of commercially available tools and specified applications for analysis, quantification and reporting. It allows multiple users fast access to, and exchange of specific and/or multiple cardiology exams. Philips IntelliSpace Cardiovascular software runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using standard protocols. Philips IntelliSpace Cardiovascular will also be made available for use on specified Cardiovascular Monitoring Systems, which use suitable hardware components. The modular design allows configurability to tailor the image import, archive and communications solution to one's particular budgetary and performance needs. The number of modalities and reporting and/or viewing sites can be configured per system. | | | Technological Characteristics | | | | Data type | • CT data in DICOM format (vendor independent) | • CT data in DICOM format (vendor independent) | • Any image modality data in DICOM format (vendor independent) | | Input of Patient Data | • Manual through keyboard/mouse • Command line interface | • Manual through keyboard/mouse • Command line interface | • Manual through keyboard/mouse • Command line interface | | Study list image functionality | • Exporting • Deleting • Anonymizing (no automatic deletion of original patient data) • Search | • Exporting • Deleting • Anonymizing (no automatic deletion of original patient data) • Search | Full patient/study list support | | Centreline extraction | • Realign orthogonal MPRs • Segmentation toolset: - Automatic segmentation - Automatic centreline - Manual centreline | • Realign orthogonal MPRs • Segmentation toolset: - Automatic segmentation - Automatic centreline - Manual centreline | (Features not mentioned since they are not relevant for the equivalence) | | | New Device | Predicate Device | Predicate Device | | Device name | 3mensio Workstation | 3mensio Workstation | Intellispace Cardiovascular…