# K183034: MOSAIQ Oncology Information System

- Pathway: 510(k) (Traditional)
- Applicant: Elekta, Inc.
- Decided: Dec 4, 2018 after 33 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K954874 (1996). 45 ancestors in all.
12 later devices descend from it; 2 cite 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)
- K141572: Mosaiq Oncology Information System, Impac Medical Systems, Inc. (2014) Summary page 5.

## Most influential descendants
- 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
- K222312: RayStation 12A (2023), 2 descendants of its own

## Recalls of this device
- Sep 2, 2021 · Class II · Z-2591-2021: A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
- Apr 20, 2021 · Class II · Z-1783-2021: Malware attack

## 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. • Observation of Intrafractional motion with real time image overlay. 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/K183034
Methodology: https://510kreport.com/methodology