510(k) · Cleared
ClearedPreview Shoulder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genesis Software Innovations · QIH Automated Radiological Image Processing Software
Cleared on Apr 21, 2021 as substantially equivalent to K182464 (Peek Health, S.A., 2018) after a 55-day review. Its family tree reaches back 9 generations to 1990. 3 later devices descend from it.
- Decided
- Apr 21, 2021
- Review
- 55 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K896095 (1990). 22 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 5 generations between
- 3 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 2 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 1 generation backK182464 PeekMedPeek Health, S.A. · 2018
- This deviceK210556 Preview ShoulderGenesis Software Innovations · 2021
- Descendant · cites it directly · 1 of its ownK213779 Customize3D-Side S.A. · 2022
- Descendant · cites it directly · 0 of its ownK240172 Preview ShoulderGenesis Software Innovations · 2024
- Descendant · 2 generations on · 0 of its ownK221432 Customize3D-Side S.A. · 2022
Show all 9 generations
- Root · 9 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 8 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 7 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 6 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 5 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 4 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 3 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 2 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 1 generation backK182464 PeekMedPeek Health, S.A. · 2018
- This deviceK210556 Preview ShoulderGenesis Software Innovations · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −8 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −7 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −6 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −5 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −4 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −3 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| −2 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| −1 | K182464 | PeekMed | Peek Health, S.A. | 2018 | — |
| 0 (this device) | K210556 | Preview Shoulder | Genesis Software Innovations | 2021 | — |
| +1 | K213779 | Customize | 3D-Side S.A. | 2022 | — |
| +1 | K240172 | Preview Shoulder | Genesis Software Innovations | 2024 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K182464 | PeekMedSummary page 4…ions system; Class II Product Code: QIH Classification Panel: Radiology Substantially Equivalent Devices: Peek Health, S.A. PeekMed (K182464) Reference Device: Pixmeo SARL, Osirix MD (K101342) Intended Use / Indications: The Preview Shoulder software is inte… | 2018 |
| † | K101342 | Osirix MD | 2010 |
What descends from it? (3)
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 31 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 5 of the 22 ancestors have a recall of any class.
- Of its descendants, K213779 (3D-Side S.A., 2022) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K182464.
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. 2021, 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?
The Preview Shoulder software is intended to be used as a tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study. The import process allows the user to select a DICOM CT scan series from any location that the user’s computer sees as an available file source. 3D digital representations of various implant models are available in the planning software. Preview Shoulder allows the user to digitally perform…
Read the full statement (151 words)
The Preview Shoulder software is intended to be used as a tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study.
The import process allows the user to select a DICOM CT scan series from any location that the user’s computer sees as an available file source.
3D digital representations of various implant models are available in the planning software. Preview Shoulder allows the user to digitally perform the surgical planning by showing a representation of the patient’s shoulder anatomy as a 3D model and allows the surgeon to place the implant in the patient’s anatomy.
The software allows the surgeon to generate a report, detailing the output of the planning activity.
Experience in usage and a 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210556: Preview Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210556
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