510(k) · Cleared
ClearedVisAR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novarad Corporation · OLO Orthopedic Stereotaxic Instrument
Cleared on May 27, 2022 as substantially equivalent to K190929 (Augmedics, Ltd., 2019) and 1 other predicate after a 128-day review. Its family tree reaches back 10 generations to 1993. 2 of the 57 devices in its family, counting itself, have a Class I recall.
- Decided
- May 27, 2022
- Review
- 128 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K924630 (1993). 56 ancestors in all, the oldest K890348 (1989). No later device cites it as a predicate yet. 2 of the 57 devices in this family, counting this one, have a Class I recall.
- 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 backK170167 True 3D Viewer SoftwareEchopixel, Inc. · 2017 · Recalled
- 1 generation backK172418 OpenSightNovarad Corporation · 2018
- This deviceK220146 VisARNovarad Corporation · 2022
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 backK170167 True 3D Viewer SoftwareEchopixel, Inc. · 2017 · Recalled
- 1 generation backK172418 OpenSightNovarad Corporation · 2018
- This deviceK220146 VisARNovarad Corporation · 2022
Class I recalls in this family
View 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 | K170167 | True 3D Viewer Software | Echopixel, Inc. | 2017 | 1 |
| −1 | K172418 | OpenSight | Novarad Corporation | 2018 | — |
| 0 (this device) | 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 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 1 |
| 2017 | 2 | 0 |
| 2019 | 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.
2 devices in this family have a Class I recall. 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 OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 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 |
|---|---|---|---|
| * | K190929 | xvision Spine system (XVS)Summary page 4…ification Name: Orthopedic Stereotaxic Instrument Regulation Number: 21 CFR 882.4560 Regulatory Class: Class II Product Code: OLO and LLZ Primary Predicate Device K190929 xvision Spine system (XVS) Augmedics Ltd. Additional Predicate Device K172418… | 2019 |
| * | K172418 | OpenSightSummary page 4…Code: OLO and LLZ Primary Predicate Device K190929 xvision Spine system (XVS) Augmedics Ltd. Additional Predicate Device K172418 OpenSight Novarad Corporation Device Description The VisAR system is… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 25 of the 56 ancestors have a recall of any class; 2 have a Class I recall.
- 4 other devices also cite its predicate K190929.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, 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 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
The VisAR System is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. VisAR is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to at least one rigid anatomical structure, such as the spine or iliac crests, can be identified relative to CT imagery of the anatomy. This can include guidance for procedures, such as Posterior…
Read the full statement (158 words)
The VisAR System is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. VisAR is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to at least one rigid anatomical structure, such as the spine or iliac crests, can be identified relative to CT imagery of the anatomy. This can include guidance for procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
VisAR displays a virtual screen for stereoscopic 3D images acquired from CT sources. It is intended to enable users to segment previously acquired 3D datasets, overlay, and register these 3D segmented datasets with the anatomy of the patient in order to support intraoperative analysis and guidance.
The virtual screen is indicated for displaying the virtual instrument location in relation to the virtual anatomy to assist in visualization and trajectory planning for both open and percutaneous surgeries.
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/K220146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220146: VisAR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220146
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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