# K141572: Mosaiq Oncology Information System

- Pathway: 510(k) (Traditional)
- Applicant: Impac Medical Systems, Inc.
- Decided: Sep 5, 2014 after 85 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K954874 (1996). 44 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123230: Mosaiq Oncology Information System, Impac Medical Systems, Inc. (2012) Summary page 5.
- K080601: Ergo++ Version 1.7, 3D Line Medical Systems S.R.L. (2008) Summary page 5.

## Most influential descendants
- 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
- K211867: RayStation 11.0 (2021), 4 descendants of its own
- K220141: RayStation 11B (2022), 3 descendants of its own

## Recalls of this device
- Apr 20, 2021 · Class II · Z-1783-2021: Malware attack
- Sep 24, 2019 · Class II · Z-1597-2020: The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.
- 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
- Dec 4, 2018 · Class II · Z-0686-2019: If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that isocenter may not be the
- Aug 3, 2018 · Class II · Z-2917-2018: Order Status Remains Approved When Should Indicate Complete.
- Jun 30, 2017 · Class II · Z-3110-2017: The table shift in the vertical direction was inverted during the use of CMA (Couch Move Assistant). Therapy may be directed to an incorrect area.
- Dec 2, 2016 · Class II · Z-0731-2017: Edits to Particle field definition parameters may not be saved when the field definition window is saved.
- Jun 17, 2016 · Class II · Z-2052-2016: It is possible that that the selected Plan-of-the Day could be accidently changed by scrolling the mouse wheel up and down and inadvertently selecting another plan.
- Dec 9, 2015 · Class II · Z-0557-2016: Incorrect drug dosage due to "Age Limit" and patient weight data item issue.
- Nov 24, 2015 · Class II · Z-0447-2016: First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their database to reflect market and formulary changes. In FDB Framework v2.0, those drugs are n
- Jul 1, 2015 · Class II · Z-2063-2015: A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones.

## 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. Use stereotactic localization to calculate set-up coordinates for treatments. 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/K141572
Methodology: https://510kreport.com/methodology