# K022411: Preciseplan 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Precision Therapy Intl., Inc.
- Decided: Sep 20, 2002 after 58 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002240 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002240: Render-Plan 3-D 4.00 & Precise-Plan 1.0, Precision Therapy Intl., Inc. (2000)

## Recalls of this device
- Sep 30, 2008 · Not classified · Z-1109-2010: The new "DICOM CT with Body Outline" method to create a patient case in PrecisePLAN 2.15 may produce incorrect results for some customers, given several input conditions encountered in the field. Disc
- Feb 5, 2008 · Not classified · Z-1556-2011: When using the 'Beam Edit" function to modify a bean in an unlocked Fraction Group, there are two conditions that may cause the user to unitentionally modify a locked fraction group.
- Jan 28, 2008 · Not classified · Z-1476-2011: PrecisePLAN generates digitally Reconstructed Radiographs (DRR;s) with a shift in the superior direction.
- Mar 15, 2006 · Not classified · Z-1406-2010: Error in dose rates which were calculated at exactly twice the expected values.

## Indications for use
The PrecisePLAP Treatment Planning System is intended to be used for planning the dosimetry of treatments in radiation therapy. PrecisePLAP provides 2 and 3 dimensional planning capabilities based upon user defined treatment plan parameters. As an option, the user may elect to use weight optimization functionality that suports Intensity Modulated Radiaton Therapy (IMRT). Using the IMRT functionality extends the 3-D conformal planning where geometric shaped apertures are created to cover target structure(s) and minimize exposure to surrounding organs at risk. It processes the inputs of the health care professional such that the desired radiation dose can be set on a radiation therapy delivery system.

Source page: https://510kreport.com/device/K022411
Methodology: https://510kreport.com/methodology