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. · QIH Automated Radiological Image Processing Software
Cleared on Mar 19, 2025 as substantially equivalent to K240926 (Peek Health, S.A., 2024) after a 70-day review. Its family tree reaches back 11 generations to 1990. 4 later devices descend from it.
- Decided
- Mar 19, 2025
- Review
- 70 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K896095 (1990). 24 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 7 generations between
- 3 generations backK182464 PeekMedPeek Health, S.A. · 2018
- 2 generations backK222767 PeekMed web (v1)Peek Health, S.A. · 2022
- 1 generation backK240926 PeekMed webPeek Health, S.A. · 2024
- This deviceK250042 PeekMed webPeek Health, S.A. · 2025
- Descendant · cites it directly · 3 of its ownK251096 PeekMed webPeek Health, S.A. · 2025
- Descendant · 2 generations on · 1 of its ownK252856 PeekMed webPeek Health, S.A. · 2025
- Descendant · 3 generations on · 0 of its ownK261641 Lower Limb AI (LLAI)AI Planning Logic, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK252452 PeekMed webPeek Health, S.A. · 2025
Show all 11 generations
- Root · 11 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 10 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 9 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 8 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 7 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 6 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 5 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 4 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 3 generations backK182464 PeekMedPeek Health, S.A. · 2018
- 2 generations backK222767 PeekMed web (v1)Peek Health, S.A. · 2022
- 1 generation backK240926 PeekMed webPeek Health, S.A. · 2024
- This deviceK250042 PeekMed webPeek Health, S.A. · 2025
Most influential descendants
Showing 4 of 4 · See all- K251096PeekMed webPeek Health, S.A. · 2025 · cites it directly3descendants
- K252856PeekMed webPeek Health, S.A. · 2025 · 2 generations on1descendant
- K261641Lower Limb AI (LLAI)AI Planning Logic, Inc. · 2026 · 3 generations on0descendants
- K252452PeekMed webPeek Health, S.A. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −10 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −9 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −8 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −7 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −6 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −5 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| −4 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| −3 | K182464 | PeekMed | Peek Health, S.A. | 2018 | — |
| −2 | K222767 | PeekMed web (v1) | Peek Health, S.A. | 2022 | — |
| −1 | K240926 | PeekMed web | Peek Health, S.A. | 2024 | — |
| 0 (this device) | K250042 | PeekMed web | Peek Health, S.A. | 2025 | — |
| +1 | K251096 | PeekMed web | Peek Health, S.A. | 2025 | — |
| +2 | K252856 | PeekMed web | Peek Health, S.A. | 2025 | — |
| +3 | K261641 | Lower Limb AI (LLAI) | AI Planning Logic, Inc. | 2026 | — |
| +2 | 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 | 3 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 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 |
|---|---|---|---|
| * | K240926 | PeekMed webSummary page 5…3. Legally Marketed Predicate Device 3.1 PeekMed web 510(k) Product Name Clearance Date K240926 PeekMed web December 6, 2024 510(k) Summary - PeekMed web… | 2024 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251096 | PeekMed web | 2025 | 3 |
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 35 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 5 of the 24 ancestors have a recall of any class.
- Of its descendants, K251096 (Peek Health, S.A., 2025) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K240926.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
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…
Read the full statement (162 words)
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.
This medical device consists of a decision support tool for qualified healthcare professionals to quickly and efficiently perform the pre-operative planning for several surgical procedures, using medical imaging with the additional capability of planning the 2D or 3D environment. The system is designed for the medical specialties within surgery and no specific use environment is mandatory, whereas the typical use environment is a room with a computer. The patient target group is adult patients who have an injury or disability diagnosed previously. There are no other considerations for the intended patient population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250042: PeekMed web.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250042
Report an extraction error
Are you the manufacturer?
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