# Sequencer > Active: United States. Medical device record on deviCERTS, compiled from public registries. - Canonical page: - Manufacturer: [Impac Medical Systems, Inc.](https://devicerts.com/manufacturers/impac-medical-systems-inc) (United States, FDA 510(k) applicant) - Name in the registry: SEQUENCER - Device class: Class II (US FDA) - FDA product code: IYE ## Overview *AI-generated summary, 2026-09-19. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.* The Sequencer is a Class 2 medical device used to facilitate the delivery of defined radiotherapy treatment plans. It is designed for use with MOSAIQ versions 1.3 and 1.4 with Elekta and Siemens Machines. The device is manufactured by Impac Medical Systems, Inc. and is supplied as a single unit. It is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided. The device has FDA 510(k) clearance with product code IYE. ## Registrations and authorizations - **510(k)** · FDA 510(k) · United States · K981313 · decision 1998-07-09 · decision SESE · status: Active ## Recalls - Z-0821-2019 · Class II · ongoing · initiated 2018-12-13: 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 wedge will receive more dose than the treatment plan indicates. - Z-1270-2012 · · terminated · initiated 2012-02-14: 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, for RT Therapist version 2.1A - Z-0052-2012 · · terminated · initiated 2011-09-09: Varian reported a problem related to certain collimator rotation values which are incorrect on TrueBeam compared to planned values in Mosaiq. - Z-2662-2011 · · terminated · initiated 2011-03-10: 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 pressing beam-on, the patient will be mistreated. - Z-0076-2011 · · terminated · initiated 2010-09-02: 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. - Z-1029-2011 · · terminated · initiated 2010-03-10: Computer interface is defected. Computer based verification system for recording patient treatment on a radiotherapy treatment machine fails to record treated field. - Z-0159-2011 · · terminated · initiated 2010-02-19 · matched through shared submission K981313, may concern other models: 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 from zero instead of the original prescribed value. - Z-1027-2011 · · terminated · initiated 2009-07-17: 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 from interstitial leaf leakage (jaw extrusion). - Z-1515-2008 · · terminated · initiated 2008-02-14: Software issue may result in change to intended treatment field, potentially resulting in mistreatment. - Z-1401-06 · · terminated · initiated 2006-07-07: Improper treatment may be delivered if the machine configuration file is edited/set for the Varian MLC revision H file format. - Z-0364-06 · · terminated · initiated 2005-01-06: 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 patients less than two years old to be seriously overdosed with radiation. ## Identifiers - 510(k) Number: K981313 [FDA 510(k)] - FDA product code: IYE [FDA 510(k)] ## Classification - Device class: Class II [FDA 510(k)] - Regulation: 21 CFR Part 892.5050 [FDA 510(k)] - Advisory committee: Radiology [FDA 510(k)] - FDA decision: SESE [FDA 510(k)] ## Source and citation - Cite as: Sequencer, Impac Medical Systems, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/sequencer-iye (data as of 2026-11-15). - Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/) - Registry records last synced: 2026-10-22 - Statuses computed as of: 2026-11-15 - JSON: - Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms. - Attribution: DevicErts, https://devicerts.com/devices/sequencer-iye - Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.