510(k) · Cleared
ClearedUNiD™ Spine Analyzer (SW3002)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicrea International S.A.S. (Medtronic) · QIH Automated Radiological Image Processing Software
Cleared on May 15, 2026 as substantially equivalent to K251629 (Medicrea International S.A.S. (Medtronic), 2025) after a 25-day review. Its family tree reaches back 14 generations to 1990.
- Decided
- May 15, 2026
- Review
- 25 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K896095 (1990). 27 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 10 generations between
- 3 generations backK180091 UNiD Spine AnalyzerMedicrea International · 2018
- 2 generations backK212005 UNiD Spine AnalyzerMedicrea International, Inc. · 2022 · Recalled
- 1 generation backK251629 UNiD™ Spine AnalyzerMedicrea International S.A.S. (Medtronic) · 2025
- This deviceK261289 UNiD™ Spine Analyzer (SW3002)Medicrea International S.A.S. (Medtronic) · 2026
Show all 14 generations
- Root · 14 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 13 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 12 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 11 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 10 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 9 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 8 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 7 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 6 generations backK111019 Surgimap (TM) SpineNemaris, Inc. · 2011
- 5 generations backK141669 SurgimapNemaris, Inc. · 2014
- 4 generations backK170172 UNiD Spine AnalyzerMedicrea International · 2017
- 3 generations backK180091 UNiD Spine AnalyzerMedicrea International · 2018
- 2 generations backK212005 UNiD Spine AnalyzerMedicrea International, Inc. · 2022 · Recalled
- 1 generation backK251629 UNiD™ Spine AnalyzerMedicrea International S.A.S. (Medtronic) · 2025
- This deviceK261289 UNiD™ Spine Analyzer (SW3002)Medicrea International S.A.S. (Medtronic) · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −13 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −12 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −11 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −10 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −9 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −8 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| −7 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| −6 | K111019 | Surgimap (TM) Spine | Nemaris, Inc. | 2011 | — |
| −5 | K141669 | Surgimap | Nemaris, Inc. | 2014 | — |
| −4 | K170172 | UNiD Spine Analyzer | Medicrea International | 2017 | — |
| −3 | K180091 | UNiD Spine Analyzer | Medicrea International | 2018 | — |
| −2 | K212005 | UNiD Spine Analyzer | Medicrea International, Inc. | 2022 | 1 |
| −1 | K251629 | UNiD™ Spine Analyzer | Medicrea International S.A.S. (Medtronic) | 2025 | — |
| 0 (this device) | K261289 | UNiD™ Spine Analyzer (SW3002) | Medicrea International S.A.S. (Medtronic) | 2026 | — |
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 |
|---|---|---|---|
| * | K251629 | UNiD™ Spine AnalyzerSummary page 6…reference devices Primary Device name UNiD™ Spine Analyzer 5.0.0 predicate 510(k) information K251629, cleared on 08/07/2025 device Common Name Automated radiological image processing… | 2025 |
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 36 years and passes through 9 companies; a new generation was cleared every 2.8 years on median.
- 6 of the 27 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. 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 UNiD™ Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic, as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261289 · printed Nov 5, 2026
Cite this page
510(k) Report. “K261289: UNiD™ Spine Analyzer (SW3002).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K261289
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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