510(k) · Cleared
ClearedbrAIn™ Shoulder Positioning
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avatar Medical · QIH Automated Radiological Image Processing Software
Cleared on Oct 20, 2025 as substantially equivalent to K213922 (Pixee Medical, 2022) after a 56-day review. Its family tree reaches back 12 generations to 1990.
- Decided
- Oct 20, 2025
- Review
- 56 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K896095 (1990). 27 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 8 generations between
- 3 generations backK160284 JointPointJointpoint, Inc. · 2016
- 2 generations backK201928 e-Ortho Shoulder SoftwareFH Industrie · 2020
- 1 generation backK213922 FX SPSPixee Medical · 2022
- This deviceK252665 brAIn™ Shoulder PositioningAvatar Medical · 2025
Show all 12 generations
- Root · 12 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 11 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 10 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 9 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 8 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 7 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 6 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 5 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 4 generations backK142923 TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015
- 3 generations backK160284 JointPointJointpoint, Inc. · 2016
- 2 generations backK201928 e-Ortho Shoulder SoftwareFH Industrie · 2020
- 1 generation backK213922 FX SPSPixee Medical · 2022
- This deviceK252665 brAIn™ Shoulder PositioningAvatar Medical · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −11 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −10 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −9 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −8 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −7 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −6 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| −5 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| −4 | K142923 | TraumaCad Mobile Release 1.0 | Voyant Health, Ltd. | 2015 | — |
| −3 | K160284 | JointPoint | Jointpoint, Inc. | 2016 | — |
| −2 | K201928 | e-Ortho Shoulder Software | FH Industrie | 2020 | — |
| −1 | K213922 | FX SPS | Pixee Medical | 2022 | — |
| 0 (this device) | K252665 | brAIn™ Shoulder Positioning | Avatar Medical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 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 23.6 · 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 |
|---|---|---|---|
| * | K213922 | FX SPSSummary page 7…evice Trade name FX SPS Common Name Planning software for Total Shoulder Arthroplasty Premarket Notification K213922 Classification Name System, Image Processing, Radiological Regulation Number 21 CFR 892.2050 Regu… | 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 35 years and passes through 10 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 27 ancestors have a recall of any class.
- 1 other device also cites its predicate K213922.
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?
brAIn™ Shoulder Positioning is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement.
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/K252665 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252665: brAIn™ Shoulder Positioning.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252665
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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