# K120067: Mosaiq Oncology Information System

- Pathway: 510(k) (Traditional)
- Applicant: Impac Medical Systems, Inc.
- Decided: Feb 28, 2012 after 50 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K942346 (1995). 10 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043412: Modification to: Viewstation, Impac Medical Systems, Inc. (2004) Summary page 2.
- K981313: Sequencer, Impac Medical Systems, Inc. (1998) Summary page 2.
- K991133: MLC Fit, Impac Medical Systems, Inc. (2000) Summary page 2.
- K093527: Aria Radiation Oncology with Mirs, Varian Medical Systems, Inc. (2009) Summary page 2.

## Most influential descendants
- K142142: Quality Reports (2014), 5 descendants of its own
- K162468: ClearCheck (2016), 4 descendants of its own
- K220583: ClearCheck Model RADCC V2 (2022), 3 descendants of its own
- K231185: MapRT (2023), 1 descendant of its own
- K122616: Panther Ois/R & V Model Version 2.0 (2012), 1 descendant 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
- Sep 18, 2012 · Class II · Z-0169-2013: A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ.
- Jun 8, 2012 · Class II · Z-1944-2012: Impac Medical became aware of a problem with the recording of the Wedge Motor Units in MOSAIQ when it resumes after a machine terminates/faults, the remaining Wedge MU was being erroneously set to zer

## Indications for use
MOSAIQ supports information flow among healthcare facility personnel. It can be used wherever radiotherapy and/or chemotherapy are prescribed. 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/K120067
Methodology: https://510kreport.com/methodology