510(k) · Cleared
ClearedCustomize
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3D-Side S.A. · QIH Automated Radiological Image Processing Software
Cleared on Aug 3, 2022 as substantially equivalent to K213779 (3D-Side S.A., 2022) after a 78-day review. Its family tree reaches back 11 generations to 1990.
- Decided
- Aug 3, 2022
- Review
- 78 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. No later device cites it as a predicate yet.
- 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 backK210556 Preview ShoulderGenesis Software Innovations · 2021
- 1 generation backK213779 Customize3D-Side S.A. · 2022
- This deviceK221432 Customize3D-Side S.A. · 2022
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 backK210556 Preview ShoulderGenesis Software Innovations · 2021
- 1 generation backK213779 Customize3D-Side S.A. · 2022
- This deviceK221432 Customize3D-Side S.A. · 2022
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 | K210556 | Preview Shoulder | Genesis Software Innovations | 2021 | — |
| −1 | K213779 | Customize | 3D-Side S.A. | 2022 | — |
| 0 (this device) | K221432 | Customize | 3D-Side S.A. | 2022 | — |
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 |
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 |
|---|---|---|---|
| * | K213779 | CustomizeSummary page 4…s claimed: Item Description Device Classification Name Automated Radiological Image Processing Software 510(k) number K213779 Trade or proprietary or Customize model name Original Applicant 3D-Side SA Regulation Number… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 5 of the 24 ancestors have a recall of any class.
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. 2022, 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?
Customize for ankle arthroplasty is intended to be used as a software interface to assist in:
- Visualization, modification, validation of the planning of total ankle arthroplasty
- Communication of treatment options
- Segmentation of CT-scan data
- 3D CAD models generation
- use x-ray scan information to enhance the planning of ankle arthroplasty
- Managing timeline and cases
Customize is not intended to be used for
- Spine surgeries
- Implant and instrument design
Experience in usage and clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221432 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221432: Customize.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221432
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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