# K103193: Doseview 3D

- Pathway: 510(k) (Traditional)
- Applicant: Standard Imaging, Inc.
- Decided: Dec 27, 2010 after 59 days
- Product code: IYE (Accelerator, Linear, 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
Longest line of descent: 1 generation back to K854880 (1986). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K854880: Radiation Beam Data Acquistioin Systems, Computerized Medical Systems, Inc. (1986) Summary page 1.
- K954165: PTW-MP3 & PTW-MP3S Automatic Water Phantom, Ptw-New York Corp. (1995) Summary page 1.

## Most influential descendants
- K232738: BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) (2024), 0 descendants of its own

## Indications for use
The DoseView 3D system is a 3 axis, water phantom scanning system intended to easily and accurately, measure and analyze pulsed photon and electron radiation from a linear accelerated-based radiation therapy system or continuous radiation from a radioactive source-based radiotherapy system. *This data is then often used in support of a radiation treatment planning system. It is comprised of a water tank, electrometer, radiation detector(s), motion controller, controlling software, master pendant and lift/reservoir cart. It is a prescription device intended to be used by a trained medical physicist. The general uses of the DoseView 3D include the following: * Acceptance testing and/or commissioning of a radiation therapy or radiotherapy system. * Quality assurance measurements to identify and minimize the sources of uncertainty and. error in the radiation therapy system, radiotherapy system or radiation treatment planning system. * Collection of dose depth data for radiation treatment planning system use. * Completion of clinical dosimetry protocols and calibrations.

Source page: https://510kreport.com/device/K103193
Methodology: https://510kreport.com/methodology
