510(k) · Cleared
ClearedOrthoview
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omsbar, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Aug 14, 2003 as substantially equivalent to K020995 (Efilm Medical, Inc., 2002) after a 10-day review. Its family tree reaches back 5 generations to 1990. 133 later devices descend from it.
- Decided
- Aug 14, 2003
- Review
- 10 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K896095 (1990). 6 ancestors in all. 133 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 4 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 3 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 2 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 1 generation backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- This deviceK032401 OrthoviewOmsbar, Ltd. · 2003
- Descendant · cites it directly · 129 of its ownK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- Descendant · 2 generations on · 117 of its ownK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- Descendant · 3 generations on · 51 of its ownK111019 Surgimap (TM) SpineNemaris, Inc. · 2011
- Descendant · 3 generations on · 28 of its ownK142923 TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015
- Descendant · 3 generations on · 27 of its ownK141669 SurgimapNemaris, Inc. · 2014
Showing 5 of 133 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 133 · See all- K042816Traumacad 1.2Orthocrat, Ltd. · 2004 · cites it directly129descendants
- K073714Traumacad Version 2.0Orthocrat, Ltd. · 2008 · 2 generations on117descendants
- K111019Surgimap (TM) SpineNemaris, Inc. · 2011 · 3 generations on51descendants
- K142923TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015 · 3 generations on28descendants
- K141669SurgimapNemaris, Inc. · 2014 · 3 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −4 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −3 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −2 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −1 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| 0 (this device) | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| +1 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| +2 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| +3 | K111019 | Surgimap (TM) Spine | Nemaris, Inc. | 2011 | — |
| +3 | K142923 | TraumaCad Mobile Release 1.0 | Voyant Health, Ltd. | 2015 | — |
| +3 | K141669 | Surgimap | Nemaris, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 6 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 9 | 0 |
| 2018 | 7 | 0 |
| 2019 | 4 | 0 |
| 2020 | 10 | 0 |
| 2021 | 13 | 0 |
| 2022 | 9 | 0 |
| 2023 | 11 | 0 |
| 2024 | 9 | 0 |
| 2025 | 23 | 0 |
| 2026 | 16 | 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 |
|---|---|---|---|
| * | K020995 | Efilm Workstation with Modules | 2002 |
What descends from it? (133)
See all 1334 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 13 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K042816 (Orthocrat, Ltd., 2004) has gone furthest, with 129 descendants of its own.
- 14 other devices also cite its predicate K020995.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
OrthoviewTM is indicated for use when a suitably licensed and qualified healthcare professional requires access to medical images with the intention of using such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032401 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032401: Orthoview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032401
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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