Vision Rt Inc

Affected software version:  Software versions 5.0.1738 and 5.0.1742 only.  Affected serial numbers:  248-052, 248-066, 248-088, 249-0059, 249-0133, 249-0134, 249-0139.

Radiology Devices

2

No

Worldwide Distribution: US distribution in states of: CA, MN, TX, and UT; and internationally to: Republic of Ireland.

AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.

Serial numbers (internally referred to as PCR numbers):   USA: 247-018, 247-039, 247-040, 247-053, 247-060, 247-061 , 247-062, 247-063, 247-068, 247-071 , 247-075, 247-076 , 247-078, 247-081, 247-083, 247-096, 247-099, 247-100,, 247-101, 247-102 , 247-110 , 247-118, 247-119, 247-122, 247-124, 247-127, 247-129, 247-130, 247-138, 247-140, 247-142, 247-149, 247-150, 247-153, 247-161, 247-167, 247-171, 247-184, 247-194, 247-200, 247-207, 247-212, 247-213, 248-012, 248-018, 248-041  Rest of the world:  247-035, 247-073, 247-114, 247-131, 247-147, 247-148, 247-188

Radiology Devices

2

No

Nationwide Distribution

AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.