# K123230: Mosaiq Oncology Information System

- Pathway: 510(k) (Traditional)
- Applicant: Impac Medical Systems, Inc.
- Decided: Dec 12, 2012 after 58 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K954874 (1996). 38 ancestors in all.
20 later devices descend from it; 2 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112930: Mobile Mim, Mim Software, Inc. (2011)

## Cited in the summary but kept off the family tree
- K120067: Mosaiq Oncology Information System, Impac Medical Systems, Inc. (2012). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K141572: Mosaiq Oncology Information System (2014), 13 descendants of its own
- K183034: MOSAIQ Oncology Information System (2018), 12 descendants of its own
- K203172: MOSAIQ Oncology Information System (2020), 8 descendants of its own
- K210645: RayStation 10.1 (2021), 5 descendants of its own
- K142142: Quality Reports (2014), 5 descendants of its own

## Recalls of this device
- Dec 13, 2018 · Class II · Z-0821-2019: There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, which will cause the field in MOSAIQ to be created with no wedge. Treatment of a field without the planned
- Jun 21, 2017 · Class II · Z-2633-2017: Retention of Outdated Information in an Order Set. In the Care Plan Library, double clicking to add or delete a Component/Procedure to an Order Set does not trigger the update of the associated Care P
- Jul 15, 2016 · Class II · Z-2293-2016: It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order.
- Nov 3, 2014 · Class II · Z-0221-2015: A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose rounding error on printed reports.
- May 29, 2014 · Class II · Z-1869-2014: MOSAIQ does not re-calculate the agent volume when the user changes the ordering dose (to other than what was calculated) prior to saving the order.
- May 23, 2014 · Class II · Z-1800-2014: When using CMA, if the user hovers the mouse pointer exactly above the direction dropdowns and then uses the mouse thumbwheel or touchpad scroll bar, the direction selection might change when the inte
- Dec 20, 2012 · Class II · Z-1077-2013: A potential safety risk with the MOSAIQ Oncology Information System that has been identified by the manufacturer IMPAC Medical Systems, Inc.

## Indications for use
MOSAIQ® is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Users can configure MOSAIQ® for Medical Oncology use, Radiation Oncology use, or the two together. It lets users: * Assemble electronic patient charts and treatment plans, order diagnostic tests, and prescribe medications. * Generate and keep medication formulary lists and calculate applicable medication dosages for medical oncology. * Import, view, annotate, adjust, enhance, manage and archive images. * Compare radiation treatment plans and evaluate dose coverage. * Design leaf plans for operation with radiotherapy treatment machines that have multileaf collimators. * Make sure radiation treatment plans imported from treatment planning systems agree with treatment machine constraints. MOSAIQ® reads actual settings from the treatment machine through the machine communication interface. It compares these settings with predefined values. If a mismatch occurs between the planned values and the actual machine settings, the system warns the user. * View reference images to setup treatment. MOSAIQ® refers to predefined settings to help treatment machine setup, and communicates patient and machine setup instructions. * Record actual delivered radiation values in an electronic chart to track treatment. MOSAIQ® is not intended for use in diagnosis. Medical oncology dose calculation functions are designed for use with patients 18 years or older only.

Source page: https://510kreport.com/device/K123230
Methodology: https://510kreport.com/methodology