# K101038: Rad II Simulator, Rad II KV Imager, Dual Rad II KV Imager

- Pathway: 510(k) (Traditional)
- Applicant: Acceletronics Digital Imaging, LLC
- Decided: Aug 17, 2010 after 125 days
- Product code: KPQ (System, Simulation, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K963624 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040192: ON-Board Imager Device, Varian Medical Systems, Inc. (2004) Summary page 1.
- K003636: Portalvision, Varian Medical Systems, Inc. (2001) Summary page 1.
- K032996: Elekta Synergy System, Elekta Oncology Systems, Ltd. (2003) Summary page 1.
- K946128: Simulix-HP, Oldelft Corp. of America (1995) Summary page 1.
- K834281: Rad II Simulator, Haynes Radiation Ltd., Inc. (1983) Summary page 1.

## Indications for use
1. Both the RAID II KV Imager and RAID 1ISimulator are used in the field of Radiation Therapy as diagnostic imaging devices for patient positioning verification prior to radiation therapy treatments for cancer. 2. Both the RAID II KV Imager and RAID 1ISimulator are permanently mounted to the Therapy Head of Linear Accelerators and Cobalt Teletherapy devices. 3. The RAID 11KV Imager is an "On Board Imager" intended for usage as a patient positioning verification device. 4. The RAID II KV Imager uses digital imaging to acquire its images, and positioning software to verify and/or adjust patient positioning prior to radiation therapy treatment via a Clinac as prescribed by a Radiation Oncologist. 5. The RAID 11Simulator is a "Therapy Attached" Simulator intended for developing and or verifying patient treatment protocols as prescribed by Radiation Oncologist. 6. The RAD 11Simulator device uses standard x-ray film to acquire its images, which are reviewed by the Therapist and or Oncologist to either verify or adjust patient positioning prior to radiation therapy treatment via a Clinac as prescribed by a Radiation Oncologist.

Source page: https://510kreport.com/device/K101038
Methodology: https://510kreport.com/methodology