510(k) · Cleared
ClearedPeekMed web
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peek Health, S.A. · LLZ System, Image Processing, Radiological
Cleared on Dec 6, 2024 as substantially equivalent to K222767 (Peek Health, S.A., 2022) after a 246-day review. Its family tree reaches back 10 generations to 1990. 6 later devices descend from it.
- Decided
- Dec 6, 2024
- Review
- 246 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K896095 (1990). 23 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations between
- 3 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 2 generations backK182464 PeekMedPeek Health, S.A. · 2018
- 1 generation backK222767 PeekMed web (v1)Peek Health, S.A. · 2022
- This deviceK240926 PeekMed webPeek Health, S.A. · 2024
- Descendant · cites it directly · 4 of its ownK250042 PeekMed webPeek Health, S.A. · 2025
- Descendant · 2 generations on · 3 of its ownK251096 PeekMed webPeek Health, S.A. · 2025
- Descendant · 3 generations on · 1 of its ownK252856 PeekMed webPeek Health, S.A. · 2025
- Descendant · 4 generations on · 0 of its ownK261641 Lower Limb AI (LLAI)AI Planning Logic, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK252452 PeekMed webPeek Health, S.A. · 2025
Show all 10 generations
- Root · 10 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 9 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 8 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 7 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 6 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 5 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 4 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 3 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 2 generations backK182464 PeekMedPeek Health, S.A. · 2018
- 1 generation backK222767 PeekMed web (v1)Peek Health, S.A. · 2022
- This deviceK240926 PeekMed webPeek Health, S.A. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K250042PeekMed webPeek Health, S.A. · 2025 · cites it directly4descendants
- K251096PeekMed webPeek Health, S.A. · 2025 · 2 generations on3descendants
- K252856PeekMed webPeek Health, S.A. · 2025 · 3 generations on1descendant
- K261641Lower Limb AI (LLAI)AI Planning Logic, Inc. · 2026 · 4 generations on0descendants
- K252452PeekMed webPeek Health, S.A. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −9 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −8 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −7 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −6 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −5 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −4 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| −3 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| −2 | K182464 | PeekMed | Peek Health, S.A. | 2018 | — |
| −1 | K222767 | PeekMed web (v1) | Peek Health, S.A. | 2022 | — |
| 0 (this device) | K240926 | PeekMed web | Peek Health, S.A. | 2024 | — |
| +1 | K250042 | PeekMed web | Peek Health, S.A. | 2025 | — |
| +2 | K251096 | PeekMed web | Peek Health, S.A. | 2025 | — |
| +3 | K252856 | PeekMed web | Peek Health, S.A. | 2025 | — |
| +4 | K261641 | Lower Limb AI (LLAI) | AI Planning Logic, Inc. | 2026 | — |
| +3 | K252452 | PeekMed web | Peek Health, S.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 5 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K222767 | PeekMed web (v1)Summary page 4…LLZ/QIH 3. Legally Marketed Predicate Device 3.1 PeekMed web 510(k) Product Name Clearance Date K222767 PeekMed web December 2022 510(k) Summary - PeekMed web… | 2022 |
What descends from it? (6)
2 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 34 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 23 ancestors have a recall of any class.
- Of its descendants, K250042 (Peek Health, S.A., 2025) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K222767.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
PeekMed web is a system designed to help healthcare professionals carry out pre-operative planning for several surgical procedures, based on their imported patients’ imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the output of the planning.
The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240926 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240926: PeekMed web.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240926
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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