Identifiers
- 510(k) Number
- K981313 FDA 510(k)
- FDA Product Code
- IYE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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.
Frequently asked questions
What is the purpose of the SEQUENCER device?
The SEQUENCER is a Class 2 medical device designed to facilitate the delivery of defined radiotherapy treatment plans. It is specifically engineered for use with MOSAIQ versions 1.3 and 1.4 when paired with Elekta and Siemens Machines.
How is the SEQUENCER supplied and what are its specifications?
The SEQUENCER is supplied as a single unit by Impac Medical Systems, Inc. The device has FDA 510(k) clearance with product code IYE, indicating it is substantially equivalent to other devices in this category.
Is the SEQUENCER a single-use device or can it be reused?
The device data does not specify whether the SEQUENCER is intended for single-use or reusable purposes. No information regarding sterility, MRI safety, or storage conditions is provided in the available documentation.
What regulatory approval does the SEQUENCER have?
The SEQUENCER has received FDA 510(k) clearance, which means it has been determined to be substantially equivalent to legally marketed devices. The clearance was granted on July 9, 1998, with the product code IYE.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K981313 FDA 510(k) - SEQUENCER | Impac Medical Systems, Inc., Impac Medical Systems Inc, Impac Medical Systems, Inc. FDA 510(k) Products (1991-2015), Impac Sequencer - allmed.wiki, Class 2 Device Recall Sequencer - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K981313 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Impac Medical Systems, Inc.
Sources (1)
- FDA 510(k) K981313 24 fields · synced Sep 19, 2026