510(k) · Cleared
ClearedCeevra Reveal 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceevra, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jul 10, 2018 as substantially equivalent to K171356 (Ceevra, Inc., 2017) after a 271-day review. Its family tree reaches back 9 generations to 1993. 17 later devices descend from it.
- Decided
- Jul 10, 2018
- Review
- 271 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K924630 (1993). 11 ancestors in all, the oldest K924810 (1993). 17 later devices descend from it, 6 citing it directly.
- Root · 9 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 5 generations between
- 3 generations backK123023 Surgery Rehearsal PlatformSurgical Theater, LLC · 2013
- 2 generations backK142107 Echo True 3D ViewerEchopixel, Inc. · 2015 · Recalled
- 1 generation backK171356 Clarity RevealCeevra, Inc. · 2017
- This deviceK173274 Ceevra Reveal 2.0Ceevra, Inc. · 2018
- Descendant · cites it directly · 5 of its ownK222676 Ceevra Reveal 3Ceevra, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK233568 Ceevra Reveal 3+Ceevra, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK222035 Avatar Medical Software V1Avatar Medical · 2023
- Descendant · cites it directly · 2 of its ownK211443 Aibolit 3D+Aibolit Technologies, LLC · 2022
- Descendant · cites it directly · 2 of its ownK182643 IRIS 1.0 SystemIntuitive Surgical · 2019
Show all 9 generations
- Root · 9 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 8 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 7 generations backK033849 Simplant SystemMaterialise NV · 2004
- 6 generations backK073468 MimicsMaterialise NV · 2008
- 5 generations backK093269 Procedure Rehearsal StudioSimbionix, Ltd. · 2010
- 4 generations backK112387 Procedure Rehearsal Studio (TM)Simbionix, Ltd. · 2011
- 3 generations backK123023 Surgery Rehearsal PlatformSurgical Theater, LLC · 2013
- 2 generations backK142107 Echo True 3D ViewerEchopixel, Inc. · 2015 · Recalled
- 1 generation backK171356 Clarity RevealCeevra, Inc. · 2017
- This deviceK173274 Ceevra Reveal 2.0Ceevra, Inc. · 2018
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K222676Ceevra Reveal 3Ceevra, Inc. · 2023 · cites it directly5descendants
- K233568Ceevra Reveal 3+Ceevra, Inc. · 2023 · 2 generations on2descendants
- K222035Avatar Medical Software V1Avatar Medical · 2023 · cites it directly2descendants
- K211443Aibolit 3D+Aibolit Technologies, LLC · 2022 · cites it directly2descendants
- K182643IRIS 1.0 SystemIntuitive Surgical · 2019 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −8 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −7 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −6 | K073468 | Mimics | Materialise NV | 2008 | — |
| −5 | K093269 | Procedure Rehearsal Studio | Simbionix, Ltd. | 2010 | — |
| −4 | K112387 | Procedure Rehearsal Studio (TM) | Simbionix, Ltd. | 2011 | — |
| −3 | K123023 | Surgery Rehearsal Platform | Surgical Theater, LLC | 2013 | — |
| −2 | K142107 | Echo True 3D Viewer | Echopixel, Inc. | 2015 | 1 |
| −1 | K171356 | Clarity Reveal | Ceevra, Inc. | 2017 | — |
| 0 (this device) | K173274 | Ceevra Reveal 2.0 | Ceevra, Inc. | 2018 | — |
| +1 | K222676 | Ceevra Reveal 3 | Ceevra, Inc. | 2023 | — |
| +2 | K233568 | Ceevra Reveal 3+ | Ceevra, Inc. | 2023 | — |
| +1 | K222035 | Avatar Medical Software V1 | Avatar Medical | 2023 | — |
| +1 | K211443 | Aibolit 3D+ | Aibolit Technologies, LLC | 2022 | — |
| +1 | K182643 | IRIS 1.0 System | Intuitive Surgical | 2019 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K171356 | Clarity RevealSummary page 4…LLZ Regulatory Class II 3. Predicate Device Proprietary Name Clarity Reveal 1.0 Premarket Notification K171356 Classification Name System, Image Processing, Radiological Regulation Number 21 CFR 892.2050 R… | 2017 |
What descends from it? (17)
See all 176 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)
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 25 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K222676 (Ceevra, Inc., 2023) has gone furthest, with 5 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Ceevra Reveal 2.0 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 or MR imaging devices. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multi-dimensional digital images. Ceevra Reveal 2.0 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 as stated in the FDA summary.
https://510kreport.com/device/K173274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173274: Ceevra Reveal 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173274
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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