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SEQUENCER

by Impac Medical Systems, Inc. 2 variants

510(k) K913612

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK913612 Date19 Dec 1991ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
IYE
Device class
Class II
Regulation
21 CFR Part 892.5050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

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Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).

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