510(k) · Cleared
Recalled · Class II · 2019RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Aug 24, 2017 as substantially equivalent to K170355 (RaySearch Laboratories AB (PUBL), 2017) after a 164-day review. Its family tree reaches back 12 generations to 2001. It has been recalled once.
- Decided
- Aug 24, 2017
- Review
- 164 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 12 generations to K010975 (2001). 67 ancestors in all, the oldest K802809 (1981). No later device cites it as a predicate yet.
- Root · 12 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 8 generations between
- 3 generations backK141860 RaystationRaysearch Laboratories AB · 2014 · Recalled
- 2 generations backK160093 RayStationRaySearch Laboratories AB (PUBL) · 2016 · Recalled
- 1 generation backK170355 RayStation 6RaySearch Laboratories AB (PUBL) · 2017 · Recalled
- This deviceK170750 RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA…Brainlab AG · 2017
Show all 12 generations
- Root · 12 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 11 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 10 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 9 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 8 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 7 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 6 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 5 generations backK102216 Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · Recalled
- 4 generations backK140187 Ray StationRaysearch Laboratories AB · 2014 · Recalled
- 3 generations backK141860 RaystationRaysearch Laboratories AB · 2014 · Recalled
- 2 generations backK160093 RayStationRaySearch Laboratories AB (PUBL) · 2016 · Recalled
- 1 generation backK170355 RayStation 6RaySearch Laboratories AB (PUBL) · 2017 · Recalled
- This deviceK170750 RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA…Brainlab AG · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −11 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −10 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −9 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −8 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −7 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −6 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −5 | K102216 | Xio RTP System | Computerized Medical Systems, Inc. | 2010 | 7 |
| −4 | K140187 | Ray Station | Raysearch Laboratories AB | 2014 | 1 |
| −3 | K141860 | Raystation | Raysearch Laboratories AB | 2014 | 5 |
| −2 | K160093 | RayStation | RaySearch Laboratories AB (PUBL) | 2016 | 7 |
| −1 | K170355 | RayStation 6 | RaySearch Laboratories AB (PUBL) | 2017 | 1 |
| 0 (this device) | K170750 | RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive… | Brainlab AG | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1994 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 MUJ? 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 MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 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 |
|---|---|---|---|
| * | K170355 | RayStation 6Summary page 4…ets SRS, Cranial SRS, Spine SRS, RT QA Common/Classific System, Planning, Radiation Therapy Treatment ation Name: Primary K170355 Raystation 6 predicate Device: Reference K142108 RT Elements Devices: K103246 iPlan RT Device class… | 2017 |
| † | K142108 | RT Elements, Dose Review, Brain Metastases, Adaptive Hybrid Surgery Analysis | 2014 |
| † | K103246 | Iplan RT | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 11, 2019 | Class II | Z-1205-2019 | Device Design | There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions) under specific circumstances when using the Pencil Beam algorithm on the GPU (graphics card), as is the default… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 22 of the 67 ancestors have a recall of any class.
- 1 other device also cites its predicate K170355.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, 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 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The "Dose Review" application as one RT Element contains features for review of isodose lines, review of DVHs, dose comparison and dose summation. The "Multiple Brain Mets SRS" application as one RT Element provides optimized planning and display for…
Read the full statement (180 words)
The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
The "Dose Review" application as one RT Element contains features for review of isodose lines, review of DVHs, dose comparison and dose summation.
The "Multiple Brain Mets SRS" application as one RT Element provides optimized planning and display for cranial multi-metastases radiation treatment planning.
The "Adaptive Hybrid Surgery Analysis" application as one RT Element simulates an automated template-based radiation treatment plan. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms.
The "Cranial SRS" application as one RT Element provides optimized planning and display for cranial radiation treatment planning.
The “Spine SRS” application as one RT Element provides optimized planning and display for single spine metastases.
"RT QA" is an accessory to the RT Elements and contains features for patient specific quality assurance.
Use "RT QA" to recalculate patient treatment plans on a phantom to verify that the patient treatment plan fulfills the planning requirements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170750 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170750: RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170750
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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