# K200487: RayCare 3.1

- Pathway: 510(k) (Traditional)
- Applicant: RaySearch Laboratories AB (PUBL)
- Decided: Jun 10, 2020 after 104 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 5 (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.
1 later device descends from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191384: RayCare 2.3, RaySearch Laboratories AB (PUBL) (2019) Summary page 4.

## Most influential descendants
- K242992: RayCare (2024A SP1) (2025), 0 descendants of its own

## Recalls of this device
- Sep 12, 2023 · Class II · Z-0206-2024: An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible for documents in a read-only state when opened outside the Documents workspace when using document field
- Jul 17, 2023 · Class II · Z-2464-2023: An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under certain circ
- Jun 8, 2021 · Class II · Z-2138-2021: Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.
- Mar 3, 2021 · Class II · Z-1281-2021: Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later
- Jul 29, 2020 · Class II · Z-2899-2020: When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to the fraction and the p

## Indications for use
RayCare is an oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. RayCare may be used in the transfer, storage, conversion and display of patient data in all areas of cancer care including radiation therapy, medical oncology and surgical oncology. RayCare is not intended for use in diagnostic activities.

Source page: https://510kreport.com/device/K200487
Methodology: https://510kreport.com/methodology