{ "format": "devicerts.device.v1", "cite_as": "Sequencer, Impac Medical Systems, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/sequencer-iye (data as of 2026-11-15).", "source": { "canonical_url": "https://devicerts.com/devices/sequencer-iye", "json_url": "https://devicerts.com/devices/sequencer-iye.json", "markdown_url": "https://devicerts.com/devices/sequencer-iye.md", "publisher": "deviCERTS (devicerts.com)", "data_sources": [ { "registry": "FDA 510(k)", "url": "https://open.fda.gov/apis/device/510k/" }, { "registry": "FDA recalls", "url": "https://open.fda.gov/apis/device/recall/" } ], "registry_records_last_synced": "2026-10-22", "status_as_of": "2026-11-15", "license": "CC BY 4.0", "license_url": "https://creativecommons.org/licenses/by/4.0/", "license_scope": "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", "disclaimer": "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." }, "device": { "name": "Sequencer", "registry_name": "SEQUENCER", "url": "https://devicerts.com/devices/sequencer-iye", "manufacturer": { "name": "Impac Medical Systems, Inc.", "url": "https://devicerts.com/manufacturers/impac-medical-systems-inc", "country": "United States", "country_basis": "FDA 510(k) applicant", "fda_registration_country": null }, "status": { "state": "active", "label": "Active", "detail": "United States" }, "classification": [ { "class": "Class II", "system": "US FDA" } ], "identifiers": [ { "label": "510(k) Number", "values": [ { "value": "K981313", "registries": [ "FDA 510(k)" ] } ] } ], "product_codes": [ "IYE" ], "emdn": [], "gmdn": [], "description": { "text": "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.\n\nThe 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.", "ai_generated": true, "generated_on": "2026-09-19", "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record." }, "noindex": false }, "authorizations": [ { "registry": "510(k)", "region": "United States", "type": "FDA 510(k)", "number": "K981313", "number_label": null, "device_udi_di": null, "date": "1998-07-09", "date_kind": "decision", "decision_code": "SESE", "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false } ], "no_longer_listed_by": [], "certificates": [], "recalls": [ { "number": "Z-0821-2019", "classification": "Class II", "status": "ongoing", "initiated": "2018-12-13", "reason": "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.", "applies": "this device", "via": "K981313" }, { "number": "Z-1270-2012", "classification": "", "status": "terminated", "initiated": "2012-02-14", "reason": "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", "applies": "this device", "via": "K981313" }, { "number": "Z-0052-2012", "classification": "", "status": "terminated", "initiated": "2011-09-09", "reason": "Varian reported a problem related to certain collimator rotation values which are incorrect on TrueBeam compared to planned values in Mosaiq.", "applies": "this device", "via": "K981313" }, { "number": "Z-2662-2011", "classification": "", "status": "terminated", "initiated": "2011-03-10", "reason": "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.", "applies": "this device", "via": "K981313" }, { "number": "Z-0076-2011", "classification": "", "status": "terminated", "initiated": "2010-09-02", "reason": "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.", "applies": "this device", "via": "K981313" }, { "number": "Z-1029-2011", "classification": "", "status": "terminated", "initiated": "2010-03-10", "reason": "Computer interface is defected. Computer based verification system for recording patient treatment on a radiotherapy treatment machine fails to record treated field.", "applies": "this device", "via": "K981313" }, { "number": "Z-0159-2011", "classification": "", "status": "terminated", "initiated": "2010-02-19", "reason": "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.", "applies": "shared submission", "via": "K981313" }, { "number": "Z-1027-2011", "classification": "", "status": "terminated", "initiated": "2009-07-17", "reason": "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).", "applies": "this device", "via": "K981313" }, { "number": "Z-1515-2008", "classification": "", "status": "terminated", "initiated": "2008-02-14", "reason": "Software issue may result in change to intended treatment field, potentially resulting in mistreatment.", "applies": "this device", "via": "K981313" }, { "number": "Z-1401-06", "classification": "", "status": "terminated", "initiated": "2006-07-07", "reason": "Improper treatment may be delivered if the machine configuration file is edited/set for the Varian MLC revision H file format.", "applies": "this device", "via": "K981313" }, { "number": "Z-0364-06", "classification": "", "status": "terminated", "initiated": "2005-01-06", "reason": "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.", "applies": "this device", "via": "K981313" } ], "eu_market_availability": null, "properties": [ { "group": "Identifiers", "fields": [ { "label": "510(k) Number", "values": [ { "value": "K981313", "registries": [ "FDA 510(k)" ] } ] }, { "label": "FDA product code", "values": [ { "value": "IYE", "registries": [ "FDA 510(k)" ] } ] } ] }, { "group": "Classification", "fields": [ { "label": "Device class", "values": [ { "value": "Class II", "registries": [ "FDA 510(k)" ] } ] }, { "label": "Regulation", "values": [ { "value": "21 CFR Part 892.5050", "registries": [ "FDA 510(k)" ] } ] }, { "label": "Advisory committee", "values": [ { "value": "Radiology", "registries": [ "FDA 510(k)" ] } ] }, { "label": "FDA decision", "values": [ { "value": "SESE", "registries": [ "FDA 510(k)" ] } ] } ] } ] }