510(k) · Cleared
ClearedClarity Reveal
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 Aug 3, 2017 as substantially equivalent to K142107 (Echopixel, Inc., 2015) after an 86-day review. Its family tree reaches back 8 generations to 1993. 18 later devices descend from it.
- Decided
- Aug 3, 2017
- Review
- 86 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K924630 (1993). 10 ancestors in all, the oldest K924810 (1993). 18 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 7 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 6 generations backK033849 Simplant SystemMaterialise NV · 2004
- 5 generations backK073468 MimicsMaterialise NV · 2008
- 4 generations backK093269 Procedure Rehearsal StudioSimbionix, Ltd. · 2010
- 3 generations backK112387 Procedure Rehearsal Studio (TM)Simbionix, Ltd. · 2011
- 2 generations backK123023 Surgery Rehearsal PlatformSurgical Theater, LLC · 2013
- 1 generation backK142107 Echo True 3D ViewerEchopixel, Inc. · 2015 · Recalled
- This deviceK171356 Clarity RevealCeevra, Inc. · 2017
- Descendant · cites it directly · 17 of its ownK173274 Ceevra Reveal 2.0Ceevra, Inc. · 2018
- Descendant · 2 generations on · 5 of its ownK222676 Ceevra Reveal 3Ceevra, Inc. · 2023
- Descendant · 3 generations on · 2 of its ownK233568 Ceevra Reveal 3+Ceevra, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK222035 Avatar Medical Software V1Avatar Medical · 2023
- Descendant · 2 generations on · 2 of its ownK211443 Aibolit 3D+Aibolit Technologies, LLC · 2022
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K173274Ceevra Reveal 2.0Ceevra, Inc. · 2018 · cites it directly17descendants
- K222676Ceevra Reveal 3Ceevra, Inc. · 2023 · 2 generations on5descendants
- K233568Ceevra Reveal 3+Ceevra, Inc. · 2023 · 3 generations on2descendants
- K222035Avatar Medical Software V1Avatar Medical · 2023 · 2 generations on2descendants
- K211443Aibolit 3D+Aibolit Technologies, LLC · 2022 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −7 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −6 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −5 | K073468 | Mimics | Materialise NV | 2008 | — |
| −4 | K093269 | Procedure Rehearsal Studio | Simbionix, Ltd. | 2010 | — |
| −3 | K112387 | Procedure Rehearsal Studio (TM) | Simbionix, Ltd. | 2011 | — |
| −2 | K123023 | Surgery Rehearsal Platform | Surgical Theater, LLC | 2013 | — |
| −1 | K142107 | Echo True 3D Viewer | Echopixel, Inc. | 2015 | 1 |
| 0 (this device) | K171356 | Clarity Reveal | Ceevra, Inc. | 2017 | — |
| +1 | K173274 | Ceevra Reveal 2.0 | Ceevra, Inc. | 2018 | — |
| +2 | K222676 | Ceevra Reveal 3 | Ceevra, Inc. | 2023 | — |
| +3 | K233568 | Ceevra Reveal 3+ | Ceevra, Inc. | 2023 | — |
| +2 | K222035 | Avatar Medical Software V1 | Avatar Medical | 2023 | — |
| +2 | K211443 | Aibolit 3D+ | Aibolit Technologies, LLC | 2022 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K142107 | Echo True 3D ViewerSummary page 4…Z Regulatory Class II 3. Predicate Device Proprietary Name EchoPixel True3D Viewer (t3 Viewer) Premarket Notification K142107 Classification Name System, Image Processing, Radiological Regulation Number 21 CFR 892.2050 R… | 2015 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173274 | Ceevra Reveal 2.0 | 2018 | 17 |
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 24 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K173274 (Ceevra, Inc., 2018) has gone furthest, with 17 descendants of its own.
- 2 other devices also cite its predicate K142107.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Clarity Reveal 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. Clarity Reveal is designed for use by healthcare 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/K171356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171356: Clarity Reveal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171356
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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