510(k) · Cleared
ClearedINT Contour
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carina Medical, LLC · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Apr 8, 2022 as substantially equivalent to K141248 (Varian Medical Systems, Inc., 2014) after a 262-day review. Its family tree reaches back 10 generations to 2001.
- Decided
- Apr 8, 2022
- Review
- 262 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K010975 (2001). 21 ancestors in all, the oldest K923851 (1992). No later device cites it as a predicate yet.
- Root · 10 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 6 generations between
- 3 generations backK102011 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · Recalled
- 2 generations backK133227 Smart Segmentation - Knowledge Based ContouringVarian Medical Systems, Inc. · 2014
- 1 generation backK141248 Smart Segmentation Knowledge Based ContouringVarian Medical Systems, Inc. · 2014
- This deviceK212274 INT ContourCarina Medical, LLC · 2022
Show all 10 generations
- Root · 10 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 9 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 8 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 7 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 6 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 5 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 4 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 3 generations backK102011 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · Recalled
- 2 generations backK133227 Smart Segmentation - Knowledge Based ContouringVarian Medical Systems, Inc. · 2014
- 1 generation backK141248 Smart Segmentation Knowledge Based ContouringVarian Medical Systems, Inc. · 2014
- This deviceK212274 INT ContourCarina Medical, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −9 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −8 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −7 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −6 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −5 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −4 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −3 | K102011 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2010 | 5 |
| −2 | K133227 | Smart Segmentation - Knowledge Based Contouring | Varian Medical Systems, Inc. | 2014 | — |
| −1 | K141248 | Smart Segmentation Knowledge Based Contouring | Varian Medical Systems, Inc. | 2014 | — |
| 0 (this device) | K212274 | INT Contour | Carina Medical, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K141248 | Smart Segmentation Knowledge Based ContouringSummary page 5…ber: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Device Class: II Product Code: MUJ 510(k) Number: K141248 510(k) Clearance Date: 09/05/2014 4. Reference Device: Trade Name: AccuContour Manufacturer: Xiamen Ma… | 2014 |
| † | K191928 | AccuContour | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 7 of the 21 ancestors have a recall of any class.
- 1 other device also cites its predicate K141248.
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. 2022, 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?
INTContour provides a machine learning-based approach for the automatic segmentation of structures including treatment targets and organs at risk to support the radiation therapy treatment planning process. INTContour is intended as an initial method to segment and contour study series; therefore, this software must be used in conjunction with an appropriate software to edit the segmentation results if necessary. It is not intended to replace a thorough…
Read the full statement (101 words)
INTContour provides a machine learning-based approach for the automatic segmentation of structures including treatment targets and organs at risk to support the radiation therapy treatment planning process. INTContour is intended as an initial method to segment and contour study series; therefore, this software must be used in conjunction with an appropriate software to edit the segmentation results if necessary. It is not intended to replace a thorough review by qualified medical professionals. INTContour is developed for use by dosimetrists, medical physicists, and radiation oncologists. The currently supported anatomical regions for automatic segmentation are head and neck, thorax, abdomen, and male pelvis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212274: INT Contour.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212274
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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