510(k) · Cleared
Recalled · Class II · 2020Primus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · IYE Accelerator, Linear, Medical
Cleared on Nov 26, 1999 as substantially equivalent to K882729 (Siemens Medical Laboratories, Inc., 1988) after a 45-day review. Its family tree reaches back 1 generation to 1988. 17 later devices descend from it. It has been recalled 50 times.
- Decided
- Nov 26, 1999
- Review
- 45 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 50
- Predicates
- 1
Its longest line of descent runs back 1 generation to K882729 (1988). 17 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK882729 Mevatron, M 2 ClassSiemens Medical Laboratories, Inc. · 1988 · Recalled
- This deviceK993425 PrimusSiemens Medical Solutions USA, Inc. · 1999
- Descendant · cites it directly · 16 of its ownK031764 Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- Descendant · cites it directly · 13 of its ownK060226 Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 11 of its ownK072485 Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · cites it directly · 9 of its ownK082775 Prescision OptionSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 2 generations on · 7 of its ownK090683 Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
2003high 4 (2009) · low 0 (2004)2026
Most influential descendants
Showing 5 of 17 · See all- K031764Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · cites it directly16descendants
- K060226Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · cites it directly13descendants
- K072485Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · 2 generations on11descendants
- K082775Prescision OptionSiemens Medical Solutions USA, Inc. · 2009 · cites it directly9descendants
- K090683Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K882729 | Mevatron, M 2 Class | Siemens Medical Laboratories, Inc. | 1988 | 38 |
| 0 (this device) | K993425 | Primus | Siemens Medical Solutions USA, Inc. | 1999 | — |
| +1 | K031764 | Oncor Avant-Garde with Coherence Workspaces | Siemens Medical Solutions USA, Inc. | 2003 | 17 |
| +1 | K060226 | Oncor Expression | Siemens Medical Solutions USA, Inc. | 2006 | 72 |
| +2 | K072485 | Artiste MV SA | Siemens Medical Solutions USA, Inc. | 2007 | 24 |
| +1 | K082775 | Prescision Option | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +2 | K090683 | Syngo RT Therapist Connect | Siemens Medical Solutions USA, Inc. | 2009 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K882729 | Mevatron, M 2 ClassSummary page 1…fication Name: Medical Charged Particle Radiation Therapy System 21 CFR § 892.5710 Class II, Product Code: RA 90 IYE 3. Predicate Device: MEVATRON™ M Class, 510(k) No. K882729 4. Description of Device: The PRIMUS™ is a dual energy, high dose medical linear accelerator. The PRIMUS™ includes dual dose rat… | 1988 |
What descends from it? (17)
See all 174 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 18, 2020 | Class II | Z-1680-2020 | Use error | Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy. |
| Mar 20, 2019 | Class II | Z-1204-2019 | Use error | Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP function for reasons of comfort is not advisable may lead to patient or user injury due to collision with LINAC equipment disabling the Auto Field… |
| Feb 14, 2018 | Class II | Z-1397-2018 | Software design | Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table. |
| Feb 14, 2018 | Class II | Z-1402-2018 | Software design | Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table. |
| Feb 14, 2017 | Class II | Z-1489-2017 | Software design | Software update |
| Jan 25, 2017 | Class II | Z-1215-2017 | Device Design | Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension. |
| Jan 25, 2017 | Class II | Z-1432-2017 | Under Investigation by firm | Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any… |
| Jul 26, 2016 | Class II | Z-2877-2016 | Software design | Software patch installation to address several safety issues. |
| Aug 5, 2015 | Class II | Z-2812-2015 | Software design (manufacturing process) | A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients. |
| May 5, 2015 | Class II | Z-0168-2016 | Software design | potential safety risk of collision of the LINAC gantry with the patient or the treatment table in case of automatically sequenced treatment delivery techniques using SIMTEC" Auto Field Sequence Option. |
| Dec 19, 2014 | Class II | Z-1059-2015 | Component design/selection | A hardware update to replace the old PCB Assembly, Head Driver-G41 with PCB with overcurrent protection as a result of reports of the electric board inside the gantry showing signs of overheating, including thermal damage and smoke… |
| Dec 2, 2014 | Class II | Z-0980-2015 | Component design/selection | Use of any unauthorized third-party components on Siemens LINACs may lead to patient or operator injury, damage to the LINAC, and can potentially compromise customer warranty. The dark current dose must be considered in the overall dose… |
| Jul 18, 2013 | Class II | Z-2095-2013 | Device Design | Siemens has become aware of a customer complaint concerning the rail threaded holes of the 550TxT treatment tabletop. Due to a manufacturing error, the screws holding the side rails in position on the tabletop might break off. |
| May 29, 2013 | Class II | Z-1663-2013 | Process change control | The information regarding the FILM Mode calibration may have been considered difficult to interpret when translated. SIEMENS HEALTHCARE CR / RADIATION ONCOLOGY had become aware that this issue may have resulted in mistreatment of patients. |
| Apr 4, 2013 | Class II | Z-1182-2013 | Software design | Software update to fix multiple safety related issues. |
| Apr 4, 2012 | Not classified | Z-1494-2012 | Process control | The firm became aware of a potential issue with Siemens-branded ONCOR or PRIMUS linear accelerator with an OPTIVUE or MVision imaging system that has the potential collision problem of the imaging panel if the panel does not retract… |
| Jan 22, 2012 | Not classified | Z-1092-2012 | Software design | Software upgrade to installed base to the latest release of the RT Therapist version 4.1.144 which corrects multiple safety issues that could lead to patient mistreatment. |
| Dec 1, 2011 | Not classified | Z-0782-2012 | Nonconforming Material/Component | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
| Jun 3, 2011 | Not classified | Z-3003-2011 | Software design | A potential safety issue was discovered when a pause for an imaging segment is inserted (where an imaging segment does not exist) with the ARTISTE and RT Therapist 4.1 system will continue to the next image. |
| May 25, 2011 | Not classified | Z-2789-2011 | Software design | Potential safety issue of possible data loss for the transfer of the same patients treatment data between the LANTIS OIS and the RTT v2.x software and the RT Therapist version 4.1 system |
| Mar 31, 2011 | Not classified | Z-2243-2011 | Software design | Siemens found a potential safety issue related to patient treatment with table offsets on syngo RT Therapist (RTT) 4.1 and 4.2 which could result in dose being delivered to wrong location. |
| Mar 31, 2011 | Not classified | Z-2216-2011 | Software design | Siemens has become aware of a potential safety issue that may result in mistreatment when customers are configured with the ARTISTE Linac RT Therapist v4.2 in combination with RT Oncologist v.4.2 and use the remote "Online 2D Image Review. |
| Mar 24, 2011 | Not classified | Z-2190-2011 | Pending | When using the ARTISTE Linac and RT Therapist v4.1 along with an imported cropped reference image, the image maybe processed incorrectly, thus resulting in a mistreatment. |
| Nov 4, 2010 | Not classified | Z-2643-2011 | Other | The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis. |
| Nov 4, 2010 | Not classified | Z-2644-2011 | Other | The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis. |
| Nov 4, 2010 | Not classified | Z-2640-2011 | Other | The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis. |
| Nov 4, 2010 | Not classified | Z-2641-2011 | Other | The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis. |
| Aug 21, 2009 | Not classified | Z-1970-2011 | Software design | When editing the note type of a previously entered note, then reverting to the original type, data may be lost. |
| Jan 11, 2008 | Not classified | Z-1396-2008 | Software design | Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact. |
| Jan 11, 2008 | Not classified | Z-1397-2008 | Software design | Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact. |
| Jan 11, 2008 | Not classified | Z-1398-2008 | Software design | Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact. |
| Dec 10, 2007 | Not classified | Z-1759-2008 | Device Design | Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards. |
| Aug 7, 2007 | Not classified | Z-0687-2008 | Device Design | Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial… |
| Aug 7, 2007 | Not classified | Z-0686-2008 | Device Design | Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial… |
| Jul 27, 2007 | Not classified | Z-0850-2008 | Component design/selection | Door Hinge failures; loose or falling off (Stationary Structure Doors) |
| Mar 23, 2007 | Not classified | Z-0380-2008 | Device Design | Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force. |
| Mar 22, 2007 | Not classified | Z-0166-2008 | Software design | Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of… |
| Mar 22, 2007 | Not classified | Z-0169-2008 | Software design | Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of… |
| Mar 22, 2007 | Not classified | Z-0167-2008 | Software design | Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of… |
| Mar 22, 2007 | Not classified | Z-0168-2008 | Software design | Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of… |
| Jan 8, 2003 | Not classified | Z-0355-06 | Other | Incomplete installation of the optional Beam Shield may allow unexpected doses of radiation outside the radiation protected areas. |
| Mar 5, 13 | Class II | Z-1040-2013 | Software design (manufacturing process) | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance… |
| Mar 5, 13 | Class II | Z-1041-2013 | Software design (manufacturing process) | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance… |
| Mar 5, 13 | Class II | Z-1043-2013 | Software design (manufacturing process) | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance… |
| Mar 5, 13 | Class II | Z-1036-2013 | Software design (manufacturing process) | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance… |
| Mar 5, 13 | Class II | Z-1039-2013 | Software design (manufacturing process) | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance… |
| Mar 5, 13 | Class II | Z-1044-2013 | Software design (manufacturing process) | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance… |
| Mar 5, 13 | Class II | Z-1042-2013 | Software design (manufacturing process) | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance… |
| Mar 5, 13 | Class II | Z-1038-2013 | Software design (manufacturing process) | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance… |
| Mar 5, 13 | Class II | Z-1037-2013 | Software design (manufacturing process) | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance… |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYE
12in 2025
2007high 28 (2012) · low 9 (2024)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
2007high 239 (2024) · low 44 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
2007high 78 (2007) · low 1 (2024)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
2007high 280 (2011) · low 66 (2022)2025
MAUDE reports naming product code IYE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The intended use of the PRIMUS™ is to deliver x-ray radiation for therapeutic treatment of cancer. The intended use of the PRIMUS™ is the same as the MEVATRON™ M and has not changed as a result of the modification.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993425 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993425: Primus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993425
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026