510(k) K092145 ยท IYE Accelerator, Linear, Medical
160MLC OPTION
| Applicant | Siemens Medical Solutions USA, Inc., Concord CA, US |
| Decision | Substantially Equivalent, Sep 18, 2009 |
| Received | Jul 15, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092145
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
COHERENCE AG T Terminated |
IYE | None listed |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
COHERENCE TH, Terminated |
IYE | None listed |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
COHERENCE Impre Terminated |
IYE | None listed |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
COHERENCE TH 2. Terminated |
IYE | None listed |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
COHERENCE TH 2. Terminated |
IYE | None listed |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
COHERENCE TH 2. Terminated |
IYE | None listed |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
Primeview 3i, P Terminated |
IYE | None listed |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
Primeview 3i 2 Terminated |
IYE | None listed |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
Primeview 3i 2 Terminated |
IYE | None listed |
| May 7, 2012 | Siemens Medical Solutions USA, Inc ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be affected are: ARTISTE MV System; ONCOR Avant Garde ONCOR Impression ONCOR Impre Terminated |
IYE | None listed |
| Jun 2, 2011 | Siemens Medical Solutions USA, Inc ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be affected are:
ARTISTE MV System;
ONCOR Avant Garde
ONCOR Impression
ONCOR Impre Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.