# K981313: Sequencer

- Pathway: 510(k) (Traditional)
- Applicant: Impac Medical Systems, Inc.
- Decided: Jul 9, 1998 after 90 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
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K120067: Mosaiq Oncology Information System (2012), 8 descendants of its own
- 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

## 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
- Feb 14, 2012 · Not classified · Z-1270-2012: Images used in treatment planning may belong to another patient. Risk of treatment to wrong area. Software update to upgrade Siemens installed base to the latest release of MOSAIQ version 2.00X3 SP5, 
- Sep 9, 2011 · Not classified · Z-0052-2012: Varian reported a problem related to certain collimator rotation values which are incorrect on TrueBeam compared to planned values in Mosaiq.
- Mar 10, 2011 · Not classified · Z-2662-2011: There's a problem in the database conversion program that is used when upgrading from the Multi-ACCS to MOSAIQ or from one version of MOSAIQ to another. If the gantry start angle is incorrect prior to
- Sep 2, 2010 · Not classified · Z-0076-2011: Software issue-- matching criteria can be configured that permits an invalid patient match, resulting in overwriting of patient records with information from a different patient.
- Mar 10, 2010 · Not classified · Z-1029-2011: Computer interface is defected. Computer based verification system for recording patient treatment on a radiotherapy treatment machine fails to record treated field.
- Feb 19, 2010 · Not classified · Z-0159-2011: Mistreatment-- The database conversion utility used during the upgrade errantly changes the start gantry angle to zero. Any affected treatment fields, if not already treated, would start delivering fr
- Jul 17, 2009 · Not classified · Z-1027-2011: Potential for improper treatment. A software error may result in potential major underdosing to targeted areas from jaw blockage of the MLC aperture (jaw intrusion), and dosing to non-targeted areas f
- Feb 14, 2008 · Not classified · Z-1515-2008: Software issue may result in change to intended treatment field, potentially resulting in mistreatment.
- Jul 7, 2006 · Not classified · Z-1401-06: Improper treatment may be delivered if the machine configuration file is edited/set for the Varian MLC revision H file format.
- Jan 6, 2005 · Not classified · Z-0364-06: When using the Creatine Clearance dose calculations a software bug will allow the algorithm to assume a patients age to be in years when it is entered in months. This miscalculation may result in pati

## Indications for use
SEQUENCER is to be used to facilitate the delivery of defined radiotherapy treatment plans. SEQUENCER verifies the settings on a radiotherapy treatment machine prior to treatment and records the actual parameters after treatment. SEQUENCER can be used whenever radiotherapy treatment is prescribed.

Source page: https://510kreport.com/device/K981313
Methodology: https://510kreport.com/methodology