Who is the manufacturer of VSI HoloMedicine?

Apoqlar GmbH filed the 510(k) submission for VSI HoloMedicine (K213215).

What is the FDA product code for VSI HoloMedicine?

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

What is the regulatory pathway for VSI HoloMedicine?

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

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

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.

VSI HoloMedicine

K213215 · Apoqlar GmbH · LLZ · Nov 25, 2022 · Radiology

Device Facts

Record ID	K213215
Device Name	VSI HoloMedicine
Applicant	Apoqlar GmbH
Product Code	LLZ · Radiology
Decision Date	Nov 25, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

VSI HoloMedicine® is a software device for displaying digital medical images acquired from CT, Angio CT, MRI, CBCT, PET, and SPECT sources. It is intended to visualize 3D imaging holograms of the patient for pre-operative planning outside and/or inside the surgical room. When accessing VSI HoloMedicine® from a wireless head-mounted display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. VSI HoloMedicine® is indicated for use by qualified healthcare professionals including surgeons, radiologists, physicians, and technologists.

Device Story

VSI HoloMedicine is a software-based medical image management and processing system. It ingests digital medical images (CT, Angio CT, MRI, CBCT, PET, SPECT) and transforms them into 3D holographic visualizations. The system operates on a Microsoft HoloLens 2 head-mounted display (HMD) or PC monitor. Used by surgeons, radiologists, and physicians for pre-operative planning in clinical or surgical environments. The software provides tools for image manipulation (rotation, arrangement, level adjustment) and MPR/3D volume rendering. It supports spatial mapping to represent real-world surfaces. Output is viewed by the clinician to assist in understanding patient anatomy and pathology. The device does not provide diagnostic-grade interpretations; it serves as an informational tool for surgical planning. Data transmission between the headset and computer is wireless and encrypted (256-bit).

Clinical Evidence

Bench testing only. Performance data included visual quality testing on software using the Microsoft HoloLens headset and software verification testing to ensure intended performance under specified use conditions.

Technological Characteristics

Software-based medical image management system. Operates on Microsoft HoloLens 2 HMD or PC. Supports DICOM, OBJ, STL, JPEG, PNG, MP4, PDF. Features include MPR, 3D volume rendering, and spatial mapping. Connectivity via encrypted wireless (256-bit). Complies with EN ISO 13485, EN ISO 14971, EN 62304, IEC 62366-1, IEC 82304-1, and ISO/TR 20416.

Indications for Use

Indicated for qualified healthcare professionals (surgeons, radiologists, physicians, technologists) for pre-operative planning using 3D imaging holograms derived from CT, Angio CT, MRI, CBCT, PET, and SPECT data. Intended for use inside or outside the surgical room. Images are for informational purposes only, not for diagnostic use.

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

SurgicalAR (K190764)

Reference Devices

Novarad-OpenSight (K172418)

Related Devices

K230249 — Ikshana · Immersivetouch · Oct 16, 2023
K190764 — SurgicalAR · Medivis, Inc. · May 13, 2019
K232339 — Augmented Reality Application · Sira Medical, Inc. · Feb 1, 2024
K251577 — LAIA XR · Augmented Reality Software S.L. · Feb 6, 2026
K173274 — Ceevra Reveal 2.0 · Ceevra, Inc. · Jul 10, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 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. ApoQlar GmbH % Liliana Duarte Chief Regulatory Affairs Officer c/o the-labs.space, Raboisen 32,20095 HAMBURG, GERMANY November 25, 2022 Re: K213215 Trade/Device Name: VSI HoloMedicine® Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: October 18, 2022 Received: October 19, 2022 Dear Liliana Duarte: We have reviewed vour 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 {1}------------------------------------------------ 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 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 mediation-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, Jessica Lamb Jessica Lamb. 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 Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213215 Device Name VSI HoloMedicine® ### Indications for Use (Describe) VSI HoloMedicine® is a software device for displaying digital medical images acquired from CT, Angio CT, MRI, CBCT, PET, and SPECT sources. It is intended to visualize 3D imaging holograms of the patient for pre-operative planning outside and/or inside the surgical room. When accessing VSI HoloMedicine® from a wireless head-mounted display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. VSI HoloMedicine® is indicated for use by qualified healthcare professionals including surgeons, radiologists, physicians, and technologists. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 5.1 General Information ### Primary Submission Contact Liliana Duarte Chief Regulatory Affairs Officer apoQlar GmbH c/o the-labs.space, Raboisen 32,20095 Hamburg, Germany Mobile: +49 157 337 455 71 Phone: +49 40 241 927 79 Email: liliana.duarte@apoqlar.com ### Manufacturer / Submitter Liliana Duarte Chief Regulatory Affairs Officer apoQlar GmbH c/o the-labs.space, Raboisen 32,20095 Hamburg, Germany Mobile: +49 157 337 455 71 Phone: +49 40 241 927 79 Email: liliana.duarte@apoqlar.com #### 5.2 Regulatory Information | Subject Device Name | VSI HoloMedicine® | |-----------------------|------------------------------------------------| | Classification Names | Medical Image Management and Processing System | | Device Classification | II | | Common Name | VSI HoloMedicine® | | FDA Product Code | LLZ | | CFR References | 892.2050 | | Review Panel | Radiology | {4}------------------------------------------------ #### 5.3 Identification of Predicate Device ApoQlar regards the VSI HoloMedicine® to be substantially equivalent to the predicate K190764 the Medivis-SurgicalAR. A reference device is also used for comparison, K172418 Novarad-OpenSight. #### 5.4 Subject Device Description VSI HoloMedicine is a software device for displaying digital medical images acquired from CT, Angio CT, MRI, CBCT, PET, and SPECT sources. It is intended to visualize 3D imaging holograms of the patient for pre-operative planning outside and/or inside the surgical room. When accessing VSI HoloMedicine from a wireless head-mounted display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. VSI HoloMedicine is indicated for use by qualified healthcare professionals including surgeons, radiologists, physicians, and technologists. ## Indications for Use VSI HoloMedicine is a software device for displaying digital medical images acquired from CT, Angio CT, MRI, CBCT, PET, and SPECT sources. It is intended to visualize 3D imaging holograms of the patient for pre-operative planning outside and/or inside the surgical room. When accessing VSI HoloMedicine from a wireless head-mounted display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. VSI HoloMedicine is indicated for use by qualified healthcare professionals including surgeons, radiologists, physicians, and technologists. #### ર્સ્ડ Substantial Equivalence Discussion Any modifications between the predicate device and the subject device are provided in while the table below. The review of the indications for use and comparison characteristics provided in Table 1 demonstrate that VSI HoloMedicine® is substantially equivalent to the predicate device. A reference device was also included. {5}------------------------------------------------ | Item No. | Device Characteristic | Proposed Device VSI HoloMedicine® | Primary Predicate Device SurgicalAR K190764 | Reference Device: Novarad- OpenSight K172418 | Comparison Analysis: Identical / Substantially Equivalent / Modified / Cannot Be Determined / Not Applicable | Rationale as to why Modification or Difference from Predicate to Subject Device Does Not Impact Safety and Effectiveness : | |-------------|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | 510 (k) Number | K213215 | K190764 | K172418 | N/A | Difference in 510k numbers do not impact safety or efficacy of the product. | | 2 | Device Name, Model | VSI HoloMedicine® | SurgicalAR | OpenSight | N/A | N/A | | 3 | Manufacturer | apoQlar GmbH | Medivis | Novarad | N/A | N/A | | 4 | CFR Reference | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | Identical | N/A | | 5 | FDA Review Panel | Radiology | Radiology | Radiology | Identical | N/A | | 6 | FDA Device Name | System, Image Processing, Radiological | System, Image Processing, Radiological | System, Image Processing, Radiological | Identical | N/A | | 7 | FDA Product Code | LLZ | LLZ | LLZ | Identical | N/A | | 8 | Class | II | II | II | Identical | N/A | | 9 | Indications for use | VSI HoloMedicine is a software device for displaying digital medical images acquired from CT, Angio CT, MRI, CBCT, PET, and SPECT sources. It is intended to visualize 3D imaging holograms of the patient for pre-operative planning outside and/or inside the surgical room. When accessing VSI HoloMedicine from a wireless head-mounted display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. VSI HoloMedicine is indicated for use by qualified healthcare professionals including surgeons, radiologists, physicians, and technologists. | SurgicalAR is a software device for display of medical images and other healthcare data. It includes functions for image review image manipulation, basic measurements, and 3D visualization (MPR reconstructions and 3D volume rendering). Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used. Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance. SurgicalAR software is | OpenSight is intended to enable users to display, manipulate, and evaluate 2D, 3D, and 4D digital images acquired from CR, DX, CT, MR, and PT sources. It is intended to visualize 3D imaging holograms of the patient, on the patient, for pre- operative localization and pre-operative planning of surgical options. OpenSight is designed for use only with performance-tested hardware specified in the user documentation. OpenSight is intended to enable users to segment previously acquired 3D datasets, overlay, and register these 3D segmented datasets with the same anatomy of the patient in order to support pre-operative analysis. OpenSight is not intended for intraoperative use. It is not to be used for stereotactic procedures. OpenSight is intended for use by trained healthcare | Substantially Equivalent | N/A | | | | | healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians and technologists. When accessing SurgicalAR software from a wireless stereoscopic head-mounted display (HMD) or mobile device, images viewed are for informational purposes only and not intended for diagnostic use. | surgeons, radiologists, chiropractors, physicians, cardiologists, technologists, and medical educators. The device assists doctors to better understand anatomy and pathology of patient. | | | | 10 | Intended Use Environment | The software is intended to be used: • In operating rooms • In office environments within hospitals or at any other location with a computer • For informational only | The software is intended to be used: • In operating rooms • In office environments within hospitals or at any other location with a computer • For informational only | Healthcare settings, such as hospitals and clinics | Identical | N/A | | | | purposes at any location using the head-mounted display (HMD) | purposes at any location using the head-mounted display (HMD) | | | | | 11 | Intended Users | Qualified healthcare professionals including surgeons, radiologists, physicians. | Qualified healthcare professionals, including but not restricted to surgeons, radiologists, nonradiology specialists, physicians, and technologists. | Qualified healthcare professionals, including surgeons, radiologists, chiropractors, physicians, cardiologists, technologists, and medical educators. | Identical | N/A | | 12 | Patient Population | The device is a software which allows for viewing of DICOM data. Therefore, its intended use is without any restrictions regarding patient population. | The device is software which allows for viewing of DICOM data. Therefore, there is no specific patient population. | OpenSight is a medical image viewer software. Therefore, specific information on the intended disease, condition, and patient population is not applicable. | Identical | N/A | | 13 | Prescription or OTC | Prescription | Prescription | Prescription | Identical | N/A | | 14 | Main System components | VSI HoloMedicine® software, and Headset (Microsoft HoloLens 2) | SurgicalAR software Headset((Microsoft HoloLens 2) | Novarad PACS Viewer software. OpenSight headset (Microsoft HoloLens) Box (23.6 cm width by 18.8 cm height by 29.6 cm long) with copper BB's | Substantially Equivalent | N/A | | 15 | Spatial Mapping | Spatial mapping provides a representation of real-world surfaces around the device | Spatial mapping provides a representation of real-world surfaces around the device | Spatial mapping provides a representation of real-world surfaces around the device | Substantially Equivalent | N/A | | 16 | Imaging Modality | CT, Angio CT, MRI, CBCT, PET CT and SPECT CT | CT/MR | CR, DX, CT, MR, and PET | Substantially Equivalent | N/A | | 17 | Data Type Supported | • DICOM • OBJ • STL • JPEG • PNG • MP4 • PDF | • DICOM • Non-DICOM | OpenSight is Radiological Image Processing System, which retrieves, stores, and displays images from DICOM compliant medical imaging modalities and/or systems. | Substantially Equivalent | N/A | | 18 | Image View/Manipulation | • Level • Reset • Image Rotate • Manually arranging object dimensions | • Image Zoom • Pan • Window Level • AutoWindow • Level • Reset • Scout Lines • Image Rotate • Image Flip • Magnify | • Image Zoom • Level • Reset • Image Rotate • Manually arranging object dimensions | Substantially Equivalent | N/A | | 19 | Communication between Headset and computer | Wireless, encrypted | Wireless, encrypted | Wireless, encrypted | Identical | N/A | | 20 | Data Encryption | • HTTPS • SSL | • HTTPS • SSL | 256 encryption | Identical | N/A | | 21 | Patient Demographic Display | Only the external ID that is provided to the patient after signing the patient agreement is displayed | Capable of displaying patient demographic information | Not Listed…