Identifiers
- 510(k) Number
- K913612 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 II medical device in the Radiology specialty, identified as an Accelerator, Linear, Medical device type. It received FDA 510(k) clearance under K913612 on December 19, 1991, as substantially equivalent to a predicate device.
The device is manufactured by Impac Medical Systems, Inc., located in Palo Alto, CA, and is used to facilitate the delivery of defined radiotherapy treatment plans. It is supplied as a non-sterile, reusable device for use in clinical radiology settings, with no indication of sterility, single-use status, or MRI safety provided in the data.
Frequently asked questions
What is the SEQUENCER used for?
The SEQUENCER is used to facilitate the delivery of defined radiotherapy treatment plans in clinical radiology settings, as stated in its description.
Is the SEQUENCER sterile or single-use?
The SEQUENCER is supplied as a non-sterile, reusable device, with no indication of sterility or single-use status provided in the data.
Who manufactures the SEQUENCER and where are they located?
The SEQUENCER is manufactured by Impac Medical Systems, Inc., located at 182 University Ave., Palo Alto, CA 94301, United States.
What regulatory pathway was used for the SEQUENCER's clearance?
The SEQUENCER received FDA 510(k) clearance under K913612 on December 19, 1991, as substantially equivalent to a predicate device.
What is the device classification and specialty of the SEQUENCER?
The SEQUENCER is a Class II medical device in the Radiology specialty, identified as an Accelerator, Linear, Medical device type.
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: SEQUENCER (K913612) — FDA 510 (k) | Innolitics, K981313 FDA 510(k) - SEQUENCER | Impac Medical Systems, Inc., Impac Medical Systems Inc, Impac Medical Systems, Inc. FDA 510(k) Products (1991-2015), K981313 FDA 510(k) - SEQUENCER | Impac Medical Systems, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K913612 | Class II | Active |
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Manufacturer
- Manufacturer
- Impac Medical Systems, Inc.
Sources (1)
- FDA 510(k) K913612 24 fields · synced Sep 24, 2026