510(k) · Cleared
ClearedNextMR Spine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MRI2CT, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Sep 4, 2026 as substantially equivalent to K233030 (Mriguidance B.V., 2024) after a 199-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Sep 4, 2026
- Review
- 199 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K922470 (1992). No later device cites it as a predicate yet.
- Root · 9 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- 5 generations between
- 3 generations backK221762 BoneMRI v1.4Mrlguidance B.V. · 2022
- 2 generations backK230197 BoneMRI v1.6Mriguidance B.V. · 2023
- 1 generation backK233030 BoneMRIMriguidance B.V. · 2024
- This deviceK260525 NextMR SpineMRI2CT, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- 8 generations backK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
- 7 generations backK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
- 6 generations backK172768 ZOOMZetta Medical Technologies, LLC · 2018
- 5 generations backK191688 SubtleMRSubtle Medical, Inc. · 2019
- 4 generations backK202404 BoneMRIMriguidance B.V. · 2021
- 3 generations backK221762 BoneMRI v1.4Mrlguidance B.V. · 2022
- 2 generations backK230197 BoneMRI v1.6Mriguidance B.V. · 2023
- 1 generation backK233030 BoneMRIMriguidance B.V. · 2024
- This deviceK260525 NextMR SpineMRI2CT, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K922470 | Ies, Image Enhancement System | Open Mri, Inc. | 1992 | — |
| −8 | K993802 | Sharpview Image Enhancement System | Context Vision AB | 2000 | — |
| −7 | K024028 | Sharp View Image Enhancement System | Context Vision AB | 2003 | — |
| −6 | K172768 | ZOOM | Zetta Medical Technologies, LLC | 2018 | — |
| −5 | K191688 | SubtleMR | Subtle Medical, Inc. | 2019 | — |
| −4 | K202404 | BoneMRI | Mriguidance B.V. | 2021 | — |
| −3 | K221762 | BoneMRI v1.4 | Mrlguidance B.V. | 2022 | — |
| −2 | K230197 | BoneMRI v1.6 | Mriguidance B.V. | 2023 | — |
| −1 | K233030 | BoneMRI | Mriguidance B.V. | 2024 | — |
| 0 (this device) | K260525 | NextMR Spine | MRI2CT, Inc. | 2026 | — |
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 |
|---|---|---|---|
| * | K233030 | BoneMRISummary page 6…QIH 3. Predicate Device Device Trade Name: BoneMRI Manufacturer: MRIguidance B.V Device 510(k) Clearance: K233030 Device Classification Name: Medical image management and processing system (21 CFR 89… | 2024 |
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 34 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K233030.
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?
MRI2CT NextMR Spine is an image processing software that can be used for image enhancement in MRI images. It can be used to visualize the 3D bone morphology in MRI images.
It is to be used in the lumbar spine vertebrae (L1-L5) and the sacrum.
MRI2CT NextMR Spine is indicated for use in patients 18 years and older.
MRI2CT NextMR Spine images are not intended to replace CT images in general.
MRI2CT NextMR Spine is not to be used for diagnosis or monitoring of (primary or metastatic) tumors or provide a quantitative bone mineral density diagnosis or bone quality assessment.
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/K260525 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260525: NextMR Spine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260525
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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