# K223229: MOSAIQ® OIS (Oncology Information System)

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Solutions AB
- Decided: Feb 23, 2023 after 128 days
- Product code: IYE (Accelerator, Linear, Medical)
- 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: 14 generations back to K954874 (1996). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203172: MOSAIQ Oncology Information System, Elekta Solutions AB (2020) Summary page 4.

## Recalls of this device
- May 21, 2026 · Class II · Z-2406-2026: Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
- Dec 10, 2025 · Class II · Z-1078-2026: Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial tr
- Sep 17, 2025 · Class II · Z-0503-2026: When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule.
- Jan 15, 2025 · Class II · Z-1162-2025: Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.

## 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. Medical oncology dose calculations are designed to support both adult and pediatric patients. 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 multi-leaf 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. • Monitor Intrafractional motion with real time image overlay. MOSAIQ® is not intended for use in diagnosis.

Source page: https://510kreport.com/device/K223229
Methodology: https://510kreport.com/methodology