HoloMedicine® Patient Viewer

HoloMedicine® Patient Viewer provides visualization capabilities for 3D and 2D medical data in DICOM and other file formats.

Indications for Use

Software device for 3D visualization of medical images and preoperative planning outside and/or inside the surgical room. Images from the HMD are for informational purposes only, not for diagnostic use. Indicated for surgeons, radiologists, physicians, and technologists. Training required.

⚠ Key Warnings

Must not be used for diagnosis, treatment decisions, or surgical navigation. Not a replacement for traditional medical imaging. Must not be used as sole DICOM viewer. Do not enter protected health information (PHI). Report serious incidents to apoQlar GmbH and your competent authority. For complete warnings, precautions, and contraindications, consult the eIFU.

Operating Requirements

Meta Quest 3/3S. Wi-Fi (min 30 Mbps). Internet required at all times. Meta account + HoloMedicine account. Use only within a closed network with restricted access.

Regulatory Information

• Class IIa medical device (EU MDR 2017/745). Stand-alone software. Per Prescription Only.

• Manufacturer: apoQlar GmbH, Raboisen 32, 20095 Hamburg, Germany.

• Notified Body: BSI Group The Netherlands B.V. (2797)

• SRN: DE-MF-000028758. CE 2797.

• Certificate: MDR 785996 R000

• UDI: (01)04270003491419(8012)1.0.0

• Basic UDI-DI: 42700034914PV1.XJL

• Software version: 1.0 | Device lifetime: 3 years

• eIFU: Knowledgebase.apoqlar.com/eifu.

• support@apoqlar.com

• +49 (0)40 24 192779