510(k) K981313 ยท IYE Accelerator, Linear, Medical
SEQUENCER
| Applicant | Impac Medical Systems, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Jul 9, 1998 |
| Received | Apr 10, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981313
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 13, 2018 | Elekta, Inc. MOSAIQ Oncology Information System and Sequencer
MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare f Open, Classified |
IYE | None listed |
| Mar 21, 2012 | Siemens Medical Solutions USA, Inc MOSAIQ System;
customers with Siemens branded linear accelerators with a COHERENCE RT Therapist workspace version 2.1a and the 3rd party MOSAIQ Oncology Information System.
MOSAIQ Oncology informatio Terminated |
IYE | None listed |
| Oct 17, 2011 | Impac Medical Systems Inc Impac Medical Systems Sequencer
Product Usage: The intended us of Sequencer is to assists in the process of patient treatment on a radiotherapy treatment machine. Sequencer provides the capability t Terminated |
IYE | None listed |
| Jun 24, 2011 | Impac Medical Systems Inc Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ
The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient t Terminated |
IYE | None listed |
| Feb 4, 2011 | Impac Medical Systems Inc SEQUENCER for Mosaiq interfaced to Electa SL75-5 machines.
Sequencer Verify and Record System is to assist in the process of patient treatment on a radiotherapy treatment machine with software contro Terminated |
IYE | None listed |
| Oct 28, 2010 | Impac Medical Systems Inc Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ, manufactured by Elekta Impac Software, Sunnyvale, CA.
The intended use of Sequencer (generically referred to as a verification syst Terminated |
MUJ | None listed |
| Oct 18, 2010 | Impac Medical Systems Inc Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class IIb, manufactured by Impac Medical Systems, Sunnyvale, CA. Terminated |
IYE | None listed |
| Aug 21, 2009 | Impac Medical Systems Inc SEQUENCER component of MOSAIQ versions 1.30 (all builds), 1.40 (all builds), 1.50 (all builds), 1.60 (all builds), and 2.0 (all builds). Manufactured by IMPAC Medical Systems, Inc. Sunnyvale, CA.
Th Terminated |
IYE | None listed |
| Aug 16, 2008 | Impac Medical Systems Inc SEQUENCER, MOSAIQ versions 1.3 and 1.4 with Elekta and Siemens Machines, Model number 40003-001000-RO, Manufactured by IMPAC Medical Systems, Sunnyvale, CA.
Used to facilitate the delivery of defined Terminated |
IYE | None listed |
| Aug 11, 2006 | Siemens Medical Solutions USA, Inc LANTIS XLINK (Impac MultiAccess Sequencer) on Varian accelerators with the MLC3PI interface Terminated |
IYE | None listed |
| Jan 7, 2006 | Siemens Medical Solutions USA, Inc LANTIS software with MedOnc Module;
MedOnc module is an option of the LANTIS radiotherapy treatment planning software distributed as a component of the firm''s linear accelerator used to deliver radi Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.