510(k) · Cleared
ClearedAuto-Seg (SO-0012), Spine Auto-Seg (SO-0012)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agada Medical, Ltd. · QIH Automated Radiological Image Processing Software
Cleared on Jun 29, 2026 as substantially equivalent to K231955 (Carlsmed, Inc., 2023) after a 222-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Jun 29, 2026
- Review
- 222 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K924630 (1993). 7 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 6 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 5 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 4 generations backK033849 Simplant SystemMaterialise NV · 2004
- 3 generations backK073468 MimicsMaterialise NV · 2008
- 2 generations backK183105 Mimics MedicalMaterialise NV · 2019
- 1 generation backK231955 aprevo® Digital SegmentationCarlsmed, Inc. · 2023
- This deviceK253628 Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)Agada Medical, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −5 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −4 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −3 | K073468 | Mimics | Materialise NV | 2008 | — |
| −2 | K183105 | Mimics Medical | Materialise NV | 2019 | — |
| −1 | K231955 | aprevo® Digital Segmentation | Carlsmed, Inc. | 2023 | — |
| 0 (this device) | K253628 | Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) | Agada Medical, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 |
|---|---|---|---|
| * | K231955 | aprevo® Digital SegmentationSummary page 6…ge 6 === Agada-Medical Auto-Seg: 510(k) Summary - K253628 Predicate Device Trade names: Aprevo Digital Segmentation 510(k) number: K231955 Reference Device Trade names: Formus Hip 510(k) number: K213272 Device Description: Th… | 2023 |
| † | K213272 | Formus Hip | 2023 |
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 33 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- None of the 7 ancestors has a recall.
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. 2026, 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 AGADA SPINE Auto-Seg device is image processing software intended to provide qualitative information from analysis of previously acquired Computed Tomography (CT) DICOM images. The outputs of the software analysis are to be used to support spine surgeons in assessment of musculoskeletal diseases and surgical planning for adults 18 years of age and older. Product functions include; segmentation of thoracic and lumbar vertebrae and pelvis, and…
Read the full statement (109 words)
The AGADA SPINE Auto-Seg device is image processing software intended to provide qualitative information from analysis of previously acquired Computed Tomography (CT) DICOM images. The outputs of the software analysis are to be used to support spine surgeons in assessment of musculoskeletal diseases and surgical planning for adults 18 years of age and older. Product functions include; segmentation of thoracic and lumbar vertebrae and pelvis, and labelling of vertebra and pelvis objects.
The Auto-Seg device does not provide diagnosis nor recommend treatment and is to be used only as supporting information in clinical decision making.
The device is not intended for use with patients with spinal or pelvic implants.
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/K253628 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253628: Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253628
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026