510(k) · Cleared
ClearedPeekMed
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 Oct 25, 2018 as substantially equivalent to K073714 (Orthocrat, Ltd., 2008) after a 45-day review. Its family tree reaches back 8 generations to 1990. 17 later devices descend from it.
- Decided
- Oct 25, 2018
- Review
- 45 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K896095 (1990). 21 ancestors in all. 17 later devices descend from it, 6 citing it directly.
- Root · 8 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 7 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 6 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 5 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 4 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 3 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 2 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 1 generation backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- This deviceK182464 PeekMedPeek Health, S.A. · 2018
- Descendant · cites it directly · 8 of its ownK222767 PeekMed web (v1)Peek Health, S.A. · 2022
- Descendant · 2 generations on · 6 of its ownK240926 PeekMed webPeek Health, S.A. · 2024
- Descendant · 3 generations on · 4 of its ownK250042 PeekMed webPeek Health, S.A. · 2025
- Descendant · 4 generations on · 3 of its ownK251096 PeekMed webPeek Health, S.A. · 2025
- Descendant · cites it directly · 3 of its ownK210556 Preview ShoulderGenesis Software Innovations · 2021
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K222767PeekMed web (v1)Peek Health, S.A. · 2022 · cites it directly8descendants
- K240926PeekMed webPeek Health, S.A. · 2024 · 2 generations on6descendants
- K250042PeekMed webPeek Health, S.A. · 2025 · 3 generations on4descendants
- K251096PeekMed webPeek Health, S.A. · 2025 · 4 generations on3descendants
- K210556Preview ShoulderGenesis Software Innovations · 2021 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −7 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −6 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −5 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −4 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −3 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −2 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| −1 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| 0 (this device) | K182464 | PeekMed | Peek Health, S.A. | 2018 | — |
| +1 | K222767 | PeekMed web (v1) | Peek Health, S.A. | 2022 | — |
| +2 | K240926 | PeekMed web | Peek Health, S.A. | 2024 | — |
| +3 | K250042 | PeekMed web | Peek Health, S.A. | 2025 | — |
| +4 | K251096 | PeekMed web | Peek Health, S.A. | 2025 | — |
| +1 | K210556 | Preview Shoulder | Genesis Software Innovations | 2021 | — |
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 |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 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 |
|---|---|---|---|
| * | K073714 | Traumacad Version 2.0Summary page 5…rocessing, Radiological Device Class: Class II Classification Panel: Radiology 5. Legally Marketed Predicate Device(s) 510(K) No. K073714 Clearance date 03/19/2008 Device Name TraumaCad version 2.0 Manufacturer Orthocrat, Ltd 6. Indications for Use… | 2008 |
What descends from it? (17)
See all 176 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 28 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 21 ancestors have a recall of any class.
- Of its descendants, K222767 (Peek Health, S.A., 2022) has gone furthest, with 8 descendants of its own.
- 12 other devices also cite its predicate K073714.
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?
PeekMed is a software system designed to help surgeons’ specialists carry out the pre-operative planning in a prompt and efficient manner for several surgical procedures, based on their patients’ imaging studies. The software imports diagnostics imaging studies such as x-rays, CT or magnetic resonance image (MRI). The import process can retrieve files from a CD ROM, a local folder or the PACS. In parallel, there is a database of digital representations…
Read the full statement (125 words)
PeekMed is a software system designed to help surgeons’ specialists carry out the pre-operative planning in a prompt and efficient manner for several surgical procedures, based on their patients’ imaging studies.
The software imports diagnostics imaging studies such as x-rays, CT or magnetic resonance image (MRI). The import process can retrieve files from a CD ROM, a local folder or the PACS. In parallel, there is a database of digital representations related to prosthetic materials supplied by their producing companies.
PeekMed allows health professional to digitally perform the surgical planning without adding any additional steps to that process. This software system requires no imaging study acquisition specification (no protocol). Experience in usage and a clinical assessment are necessary for a proper use of the software.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182464 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182464: PeekMed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182464
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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