# K032886: Diamond Setup 2000

- Pathway: 510(k) (Traditional)
- Applicant: K&S Assoc., Inc.
- Decided: Jan 9, 2004 after 115 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K140660: MOBIUS3D (2014), 23 descendants of its own
- K153014: Mobius3D (2016), 13 descendants of its own
- K191761: Mobius3D (2019), 5 descendants of its own
- K192424: Mobius3D (2019), 4 descendants of its own
- K171350: Collision Check (2017), 4 descendants of its own

## Indications for use
The current standard of care (AAPM, ACMP, ACR, etc.) in radiation oncology requires that the calculation results of each computer generated treatment plan be checked by some independent method. In the case of IMRT there is an additional requirement to perform measurements with ion chambers, TLD, film or other appropriate devices to ensure the accurate setup and delivery of the prescribed dose to the target organ and the limitation of dose to nearby sensitive organs. The medical physicist has the primary responsibility for these quality assurance checks and independent calculations. The intended purpose of the Diamond Edition of Setup 2000 Version 3.0 software is to provide an accurate and convenient method of independently checking, on a point dose basis, the treatment planning calculations of the primary radiation treatment-planning (RTP) computer. The primary RTP computer is capable of importing CT images of the patient, identifying target volumes, superimposing the treatment beams and optimizing the weighting and modulation of the beam to produce an acceptable radiation distribution within the patient. The Diamond Edition of Setup 2000 Version 3.0 calculates point doses under specified conditions communicated to the software through operator interaction (keyboard and mouse) or through file import.

Source page: https://510kreport.com/device/K032886
Methodology: https://510kreport.com/methodology