510(k) · Cleared
ClearedOpenSight
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novarad Corporation · LLZ System, Image Processing, Radiological
Cleared on Sep 21, 2018 as substantially equivalent to K170167 (Echopixel, Inc., 2017) and 1 other predicate after a 407-day review. Its family tree reaches back 9 generations to 1993. 5 later devices descend from it.
- Decided
- Sep 21, 2018
- Review
- 407 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K924630 (1993). 49 ancestors in all, the oldest K890348 (1989). 5 later devices descend from it, 3 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 backK170167 True 3D Viewer SoftwareEchopixel, Inc. · 2017 · Recalled
- This deviceK172418 OpenSightNovarad Corporation · 2018
- Descendant · cites it directly · 1 of its ownK221796 Cyware 4H and Cysart 4HAbys Medical · 2022
- Descendant · cites it directly · 1 of its ownK213128 IntraOp VSP Software DeviceXironetic, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK243069 Lumys (V1)Intradys · 2025
- Descendant · 2 generations on · 0 of its ownK232189 OrionXRHoth Intelligence, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK220146 VisARNovarad Corporation · 2022
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 backK170167 True 3D Viewer SoftwareEchopixel, Inc. · 2017 · Recalled
- This deviceK172418 OpenSightNovarad Corporation · 2018
Most influential descendants
Showing 5 of 5 · See all- K221796Cyware 4H and Cysart 4HAbys Medical · 2022 · cites it directly1descendant
- K213128IntraOp VSP Software DeviceXironetic, LLC · 2022 · cites it directly1descendant
- K243069Lumys (V1)Intradys · 2025 · 2 generations on0descendants
- K232189OrionXRHoth Intelligence, Inc. · 2023 · 2 generations on0descendants
- K220146VisARNovarad Corporation · 2022 · cites it directly0descendants
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 | K170167 | True 3D Viewer Software | Echopixel, Inc. | 2017 | 1 |
| 0 (this device) | K172418 | OpenSight | Novarad Corporation | 2018 | — |
| +1 | K221796 | Cyware 4H and Cysart 4H | Abys Medical | 2022 | — |
| +1 | K213128 | IntraOp VSP Software Device | Xironetic, LLC | 2022 | — |
| +2 | K243069 | Lumys (V1) | Intradys | 2025 | — |
| +2 | K232189 | OrionXR | Hoth Intelligence, Inc. | 2023 | — |
| +1 | K220146 | VisAR | Novarad Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 3 | 0 |
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K170167 | True 3D Viewer SoftwareSummary page 4…Name: Imaging Software Regulation Name: Picture archiving and communications system Regulation Number: 21 CFR 892.2050 Product Code: LLZ Primary Predicate Device K170167 True 3D Viewer Software EchoPixel Inc. Predicate Device K163622 Lu… | 2017 |
| * | K163622 | Lung VisionSummary page 4…mber: 21 CFR 892.2050 Product Code: LLZ Primary Predicate Device K170167 True 3D Viewer Software EchoPixel Inc. Predicate Device K163622 LungVision System Body Vision Medical Ltd. Novarad OpenSight 510(k) Submission | 2018… | 2017 |
What descends from it? (5)
3 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 2.1 years on median.
- 21 of the 49 ancestors have a recall of any class.
- Of its descendants, K221796 (Abys Medical, 2022) has gone furthest, with 1 descendant 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?
OpenSight is intended to enable users to display, manipulate, and evaluate 2D, 3D, and 4D digital images acquired from CR, DX, CT, MR, and PT sources. It is intended to visualize 3D imaging holograms of the patient, on the patient, for pre-operative localization and pre-operative planning of surgical options. OpenSight is designed for use only with performance-tested hardware specified in the user documentation. OpenSight is intended to enable users to…
Read the full statement (142 words)
OpenSight is intended to enable users to display, manipulate, and evaluate 2D, 3D, and 4D digital images acquired from CR, DX, CT, MR, and PT sources. It is intended to visualize 3D imaging holograms of the patient, on the patient, for pre-operative localization and pre-operative planning of surgical options. OpenSight is designed for use only with performance-tested hardware specified in the user documentation.
OpenSight is intended to enable users to segment previously acquired 3D datasets, overlay, and register these 3D segmented datasets with the same anatomy of the patient in order to support pre-operative analysis.
OpenSight is not intended for intraoperative use. It is not to be used for stereotactic procedures.
OpenSight is intended for use by trained healthcare professionals, including surgeons, radiologists, chiropractors, physicians, cardiologists, technologists, and medical educators. The device assists doctors to better understand anatomy and pathology of patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172418: OpenSight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172418
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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