510(k) · Cleared
ClearedUNiD™ Spine Analyzer
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 Aug 7, 2025 as substantially equivalent to K212005 (Medicrea International, Inc., 2022) after a 71-day review. Its family tree reaches back 13 generations to 1990. 1 later device descends from it.
- Decided
- Aug 7, 2025
- Review
- 71 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K896095 (1990). 26 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 9 generations between
- 3 generations backK170172 UNiD Spine AnalyzerMedicrea International · 2017
- 2 generations backK180091 UNiD Spine AnalyzerMedicrea International · 2018
- 1 generation backK212005 UNiD Spine AnalyzerMedicrea International, Inc. · 2022 · Recalled
- This deviceK251629 UNiD™ Spine AnalyzerMedicrea International S.A.S. (Medtronic) · 2025
- Descendant · cites it directly · 0 of its ownK261289 UNiD™ Spine Analyzer (SW3002)Medicrea International S.A.S. (Medtronic) · 2026
Show all 13 generations
- Root · 13 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 12 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 11 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 10 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 9 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 8 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 7 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 6 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 5 generations backK111019 Surgimap (TM) SpineNemaris, Inc. · 2011
- 4 generations backK141669 SurgimapNemaris, Inc. · 2014
- 3 generations backK170172 UNiD Spine AnalyzerMedicrea International · 2017
- 2 generations backK180091 UNiD Spine AnalyzerMedicrea International · 2018
- 1 generation backK212005 UNiD Spine AnalyzerMedicrea International, Inc. · 2022 · Recalled
- This deviceK251629 UNiD™ Spine AnalyzerMedicrea International S.A.S. (Medtronic) · 2025
Most influential descendants
Showing 1 of 1 · See all- K261289UNiD™ Spine Analyzer (SW3002)Medicrea International S.A.S. (Medtronic) · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −12 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −11 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −10 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −9 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −8 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −7 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| −6 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| −5 | K111019 | Surgimap (TM) Spine | Nemaris, Inc. | 2011 | — |
| −4 | K141669 | Surgimap | Nemaris, Inc. | 2014 | — |
| −3 | K170172 | UNiD Spine Analyzer | Medicrea International | 2017 | — |
| −2 | K180091 | UNiD Spine Analyzer | Medicrea International | 2018 | — |
| −1 | K212005 | UNiD Spine Analyzer | Medicrea International, Inc. | 2022 | 1 |
| 0 (this device) | K251629 | UNiD™ Spine Analyzer | Medicrea International S.A.S. (Medtronic) | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K212005 | UNiD Spine AnalyzerSummary page 5…nd reference devices Primary Device name UNiD™ Spine Analyzer predicate 510(k) information K212005, cleared on 01/12/2022 device Common Name system, image processing, radiological… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261289 | UNiD™ Spine Analyzer (SW3002) | 2026 | 0 |
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 9 companies; a new generation was cleared every 2.8 years on median.
- 6 of the 26 ancestors have a recall of any class.
- Of its descendants, K261289 (Medicrea International S.A.S. (Medtronic), 2026) has gone furthest, with 0 descendants of its own.
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?
The UNiDTM 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/K251629 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251629: UNiD™ Spine Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251629
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