510(k) · Cleared
ClearedIRISeg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Dec 16, 2025 as substantially equivalent to K242461 (Intuitive Surgical, Inc., 2024) after a 190-day review. Its family tree reaches back 12 generations to 1993.
- Decided
- Dec 16, 2025
- Review
- 190 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K924630 (1993). 14 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 12 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 8 generations between
- 3 generations backK173274 Ceevra Reveal 2.0Ceevra, Inc. · 2018
- 2 generations backK182643 IRIS 1.0 SystemIntuitive Surgical · 2019
- 1 generation backK242461 IRISegIntuitive Surgical, Inc. · 2024
- This deviceK251763 IRISegIntuitive Surgical, Inc. · 2025
Show all 12 generations
- Root · 12 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 11 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 10 generations backK033849 Simplant SystemMaterialise NV · 2004
- 9 generations backK073468 MimicsMaterialise NV · 2008
- 8 generations backK093269 Procedure Rehearsal StudioSimbionix, Ltd. · 2010
- 7 generations backK112387 Procedure Rehearsal Studio (TM)Simbionix, Ltd. · 2011
- 6 generations backK123023 Surgery Rehearsal PlatformSurgical Theater, LLC · 2013
- 5 generations backK142107 Echo True 3D ViewerEchopixel, Inc. · 2015 · Recalled
- 4 generations backK171356 Clarity RevealCeevra, Inc. · 2017
- 3 generations backK173274 Ceevra Reveal 2.0Ceevra, Inc. · 2018
- 2 generations backK182643 IRIS 1.0 SystemIntuitive Surgical · 2019
- 1 generation backK242461 IRISegIntuitive Surgical, Inc. · 2024
- This deviceK251763 IRISegIntuitive Surgical, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −11 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −10 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −9 | K073468 | Mimics | Materialise NV | 2008 | — |
| −8 | K093269 | Procedure Rehearsal Studio | Simbionix, Ltd. | 2010 | — |
| −7 | K112387 | Procedure Rehearsal Studio (TM) | Simbionix, Ltd. | 2011 | — |
| −6 | K123023 | Surgery Rehearsal Platform | Surgical Theater, LLC | 2013 | — |
| −5 | K142107 | Echo True 3D Viewer | Echopixel, Inc. | 2015 | 1 |
| −4 | K171356 | Clarity Reveal | Ceevra, Inc. | 2017 | — |
| −3 | K173274 | Ceevra Reveal 2.0 | Ceevra, Inc. | 2018 | — |
| −2 | K182643 | IRIS 1.0 System | Intuitive Surgical | 2019 | — |
| −1 | K242461 | IRISeg | Intuitive Surgical, Inc. | 2024 | — |
| 0 (this device) | K251763 | IRISeg | Intuitive Surgical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2007 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.6 · 7 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 |
|---|---|---|---|
| * | K242461 | IRISegSummary page 5…LZ Review Panel: Radiology 3. PREDICATE DEVICE INFORMATION Manufacturer Name: Intuitive Surgical, Inc. 510(k) Number: K242461, last cleared on December 10, 2024 Trade Name: IRISeg Common Name: Automated radiologica… | 2024 |
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 32 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 14 ancestors has a recall of any class.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
IRISeg is intended for use as a software application that receives DICOM compliant MR or contrast-enhanced CT images, provides manual and machine learning-enabled tools for image analysis and segmentation, and creates an output file that can be used to render a 3D model for preoperative surgical planning and intraoperative display. The use of IRISeg may include the generation of preliminary segmentations using machine learning algorithms. IRISeg is…
Read the full statement (124 words)
IRISeg is intended for use as a software application that receives DICOM compliant MR or contrast-enhanced CT images, provides manual and machine learning-enabled tools for image analysis and segmentation, and creates an output file that can be used to render a 3D model for preoperative surgical planning and intraoperative display. The use of IRISeg may include the generation of preliminary segmentations using machine learning algorithms. IRISeg is intended for use by qualified professionals. The output file is meant for visual, non-diagnostic use and shall be reviewed by clinicians who are responsible for all final patient management decisions.
The machine learning enabled kidney CT auto-segmentation tool is intended for use for adult patients with contrast-enhanced, axial kidney CT images with slice thickness 3mm or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251763 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251763: IRISeg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251763
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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