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510(k) Data Aggregation
K Number
K242205Device Name
SpectoMed (v1.0)
Manufacturer
Date Cleared
2025-01-14
(172 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Specto Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SpectoMed (v1.0) provides real-time spatial-visualization of medical imaging the manipulation, processing, review, analysis, communication and media interchange of multi-dimages of several modalities as defined by the DICOM standard, such as CT or MRI imaging datasets. Furthermore, SpectoMed (v1.0) aids the clinician in the preparation of a surgical intervention with measurements and import of compatible objects within the realistic spatial visuals of the patient's anatomy as well as their intraoperative display. SpectoMed (v1.0) is intended as an aid for assessing patient images.
Device Description
SpectoMed (v1.0) is a software-only device that allows trained medical professionals to review CT and MRI image data in three-dimensional (3D) format and/or in virtual reality (VR) and/or Augmented reality (AR) interfaces. The 3D rendered images are accessible through the software desktop application and, if desired, through compatible VR and AR headsets which are used by users for preoperative surgical planning and for display during intervention/surgery.
SpectoMed (v1.0) product is to be used to assist in medical image review. Intended users are trained medical professionals, including imaging technicians, clinicians and surgeons.
The 3D images generated using SpectoMed (v1.0) are intended as an aid for assessing CT or MR images that are used for diagnosis, preoperative planning and/or during intervention/surgery. SpectoMed (v1.0) is intended to be used in environments where the usage of a computer display or an XR system is safe such as:
- Office spaces
- · Operating rooms under these two scenarios:
- · Display of the SpectoMed (v1.0) visual output on existing monitors/screens in the operating room
- Use of XR displays in a non-sterile situation as e.g. before draping the patient or outside the sterility area, and thus strictly in compliance with sterility protocols.
SpectoMed (v1.0) is not meant to:
- · be used in a sterile environment,
- · to register 3D images to patients,
- · to be used with the user's hands on the patient during an interventional or surgical procedure.
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