Search Results

MAGIS1 / MAGIS2 is intended to aid in patient target to radiation beam set-up for administration of radiation therapy. It is indicated for all body procedures

MAGIS1 and MAGIS21 are self-supported, added-on mobile imaging systems incorporating one or two X-ray channels respectively. MAGIS is mechanically coupled to the Linac Gantry and the couch, and is capable of rotating with both. MAGIS acquires and processes stereoscopic images for deriving localization data, in the form of discrepancy between planned and actual object position. Localization methods include markers trianqulation and DRR comparisons to acquired images.

MAGIS incorporates X-ray production and detection modules mounted on extension arms attached to a Ring. The ring has a bore large enough to accommodate a patient and is operable to rotate about a horizontal axis, whereas said axis is parallel to couch direction and intersecting the isocenter.

MAGIS also incorporates a Console for user interface and for accommodation of the image acquisition, processing, display and user interface equipment.

The provided text discusses the MAGIS1 and MAGIS2 devices for radiation therapy patient setup and their substantial equivalence to predicate devices, but it does not contain any performance testing results, acceptance criteria, or details of a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information from the given input.

The document only lists the following:

• Intended Use: Aid in patient target to radiation beam set-up for administration of radiation therapy, indicated for all body procedures.
• Device Description: Self-supported, added-on mobile imaging systems (one or two X-ray channels) that acquire and process stereoscopic images for deriving localization data (markers triangulation and DRR comparisons).
• Performance Testing List: A list of IEC and FDA standards the device was tested according to, but no results or specific acceptance criteria are provided. The standards listed are:
  • IEC 60601-1 (1988) + A1(1991) + A2 (1995)
  • IEC 60601-1-1 (2000)
  • IEC 60601-1-2 (2001)+A1(2004)
  • IEC 60601-1-3 (1994)
  • IEC 60601-2-7 (1998)
  • FDA CDRH 21CFR 1020.30
  • FDA CDRH 21CFR 1020.32
  • IEC 60601-1-4 (1996) + A1(1999)
• Substantial Equivalence: Claimed based on descriptive information and performance testing (without providing details of those tests).

To answer your request, a different document containing the actual performance study details would be needed.

Ask a specific question about this device