510(k) · Cleared
ClearedIRIS 1.0 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical · LLZ System, Image Processing, Radiological
Cleared on Feb 22, 2019 as substantially equivalent to K173274 (Ceevra, Inc., 2018) after a 151-day review. Its family tree reaches back 10 generations to 1993. 2 later devices descend from it.
- Decided
- Feb 22, 2019
- Review
- 151 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K924630 (1993). 12 ancestors in all, the oldest K924810 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 6 generations between
- 3 generations backK142107 Echo True 3D ViewerEchopixel, Inc. · 2015 · Recalled
- 2 generations backK171356 Clarity RevealCeevra, Inc. · 2017
- 1 generation backK173274 Ceevra Reveal 2.0Ceevra, Inc. · 2018
- This deviceK182643 IRIS 1.0 SystemIntuitive Surgical · 2019
- Descendant · cites it directly · 1 of its ownK242461 IRISegIntuitive Surgical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK251763 IRISegIntuitive Surgical, Inc. · 2025
Show all 10 generations
- Root · 10 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 9 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 8 generations backK033849 Simplant SystemMaterialise NV · 2004
- 7 generations backK073468 MimicsMaterialise NV · 2008
- 6 generations backK093269 Procedure Rehearsal StudioSimbionix, Ltd. · 2010
- 5 generations backK112387 Procedure Rehearsal Studio (TM)Simbionix, Ltd. · 2011
- 4 generations backK123023 Surgery Rehearsal PlatformSurgical Theater, LLC · 2013
- 3 generations backK142107 Echo True 3D ViewerEchopixel, Inc. · 2015 · Recalled
- 2 generations backK171356 Clarity RevealCeevra, Inc. · 2017
- 1 generation backK173274 Ceevra Reveal 2.0Ceevra, Inc. · 2018
- This deviceK182643 IRIS 1.0 SystemIntuitive Surgical · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −9 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −8 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −7 | K073468 | Mimics | Materialise NV | 2008 | — |
| −6 | K093269 | Procedure Rehearsal Studio | Simbionix, Ltd. | 2010 | — |
| −5 | K112387 | Procedure Rehearsal Studio (TM) | Simbionix, Ltd. | 2011 | — |
| −4 | K123023 | Surgery Rehearsal Platform | Surgical Theater, LLC | 2013 | — |
| −3 | K142107 | Echo True 3D Viewer | Echopixel, Inc. | 2015 | 1 |
| −2 | K171356 | Clarity Reveal | Ceevra, Inc. | 2017 | — |
| −1 | K173274 | Ceevra Reveal 2.0 | Ceevra, Inc. | 2018 | — |
| 0 (this device) | K182643 | IRIS 1.0 System | Intuitive Surgical | 2019 | — |
| +1 | K242461 | IRISeg | Intuitive Surgical, Inc. | 2024 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | K173274 | Ceevra Reveal 2.0Summary page 4…Medical Image Processing Software Classification: Picture archiving and communications system (21 CFR 892.2050), LLZ Predicate Device: Ceevra Reveal 2.0 (K173274) Device Description: The IRIS 1.0 System is a software only device that processes medical images and delivers segmented image st… | 2018 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242461 | IRISeg | 2024 | 1 |
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 26 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K242461 (Intuitive Surgical, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K173274.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The IRIS 1.0 System is intended as a medical imaging system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from CT imaging devices. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multidimensional digital images. The IRIS 1.0 System is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
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/K182643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182643: IRIS 1.0 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182643
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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