510(k) · Cleared
ClearedSpine Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usa Paramed Medical Systems, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Apr 10, 2013 as substantially equivalent to K101295 (Paramed S.R.L., 2010) after a 128-day review. Its family tree reaches back 2 generations to 2008. 4 later devices descend from it.
- Decided
- Apr 10, 2013
- Review
- 128 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K073362 (2008). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK073362 MropenParamed S.R.L. · 2008
- 1 generation backK101295 MropenParamed S.R.L. · 2010
- This deviceK123708 Spine CoilUsa Paramed Medical Systems, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK151466 MrOpenParamed S.R.L. · 2015
- Descendant · 2 generations on · 2 of its ownK190524 MRopen 0.5 TAsg Superconductors S.P.A. · 2019
- Descendant · 3 generations on · 1 of its ownK193116 MRopen EVOAsg Superconductors S.P.A. · 2019
- Descendant · 4 generations on · 0 of its ownK242258 MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A. · 2024
Most influential descendants
Showing 4 of 4 · See all- K151466MrOpenParamed S.R.L. · 2015 · cites it directly3descendants
- K190524MRopen 0.5 TAsg Superconductors S.P.A. · 2019 · 2 generations on2descendants
- K193116MRopen EVOAsg Superconductors S.P.A. · 2019 · 3 generations on1descendant
- K242258MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K073362 | Mropen | Paramed S.R.L. | 2008 | — |
| −1 | K101295 | Mropen | Paramed S.R.L. | 2010 | — |
| 0 (this device) | K123708 | Spine Coil | Usa Paramed Medical Systems, Inc. | 2013 | — |
| +1 | K151466 | MrOpen | Paramed S.R.L. | 2015 | — |
| +2 | K190524 | MRopen 0.5 T | Asg Superconductors S.P.A. | 2019 | — |
| +3 | K193116 | MRopen EVO | Asg Superconductors S.P.A. | 2019 | — |
| +4 | K242258 | MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) | Asg Superconductors S.P.A. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2024 | 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 MOS? 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 MOS device
- #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 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 |
|---|---|---|---|
| * | K101295 | MropenSummary page 2…en found to be substantially equivalent through the 510(k) premarket notification process; Predicate Devices Paramned MrOpen 0.5T K101295 PARAWW-d'& S YS TEMrdS… | 2010 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151466 | MrOpen | 2015 | 3 |
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 5 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K151466 (Paramed S.R.L., 2015) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K101295.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 2025
MAUDE reports naming product code MOS, 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 | 16 | 19 | 0 | 4 |
| 2008 | 19 | 33 | 2 | 2 |
| 2009 | 10 | 43 | 0 | 5 |
| 2010 | 16 | 78 | 1 | 13 |
| 2011 | 25 | 57 | 0 | 7 |
| 2012 | 15 | 49 | 1 | 12 |
| 2013 | 7 | 87 | 0 | 10 |
| 2014 | 12 | 60 | 0 | 4 |
| 2015 | 6 | 58 | 2 | 5 |
| 2016 | 11 | 42 | 0 | 7 |
| 2017 | 9 | 63 | 0 | 9 |
| 2018 | 10 | 30 | 0 | 7 |
| 2019 | 3 | 178 | 8 | 8 |
| 2020 | 5 | 51 | 1 | 2 |
| 2021 | 4 | 41 | 0 | 3 |
| 2022 | 11 | 79 | 0 | 5 |
| 2023 | 10 | 59 | 0 | 4 |
| 2024 | 10 | 39 | 13 | 8 |
| 2025 | 3 | 59 | 0 | 2 |
| 2026 | 10 | 45 | 0 | — |
What is it indicated for?
The intended use of the SPINE COIL is to enable the MrOpen K101295 systems designed by Paramed to perform MR scan of the human spine either in the conventional recumbent position or with the patient sitting or standing (weight-bearing). The SPINE COIL inherits the same limitations of the Tomograph. The SPINE COIL enables the MRif System to which it is applied to acquire images of the Spine in transverse, sagittal, coronal and oblique cross-sectional…
Read the full statement (127 words)
The intended use of the SPINE COIL is to enable the MrOpen K101295 systems designed by Paramed to perform MR scan of the human spine either in the conventional recumbent position or with the patient sitting or standing (weight-bearing). The SPINE COIL inherits the same limitations of the Tomograph. The SPINE COIL enables the MRif System to which it is applied to acquire images of the Spine in transverse, sagittal, coronal and oblique cross-sectional directions. The images which are produced correspond to spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon MR parameters (spin-lattice relaxation time (TI), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful informnation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123708 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123708: Spine Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123708
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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