510(k) · Cleared
Recalled · Class II · 2017Duoflex Coil Suite (1.5T)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mr Instruments, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jul 25, 2013 as substantially equivalent to K110610 (Ge Medical Systems, LLC, 2011) after a 132-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 25, 2013
- Review
- 132 days
- Class
- Class II
- Product code
- MOS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K042844 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK042844 GE Signa Excite 1.5T 6 Channel Phased Array Flex Coil, GE Signa…Ge Medical Systems, Inc. · 2004
- 1 generation backK110610 1.5 GE 6-Channel Phased Array Flex Coil, 3.0 GE 6-Channel Phased…Ge Medical Systems, LLC · 2011 · Recalled
- This deviceK130706 Duoflex Coil Suite (1.5T)Mr Instruments, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK173290 DuoFLEX Coil SuiteMr Instruments, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K173290DuoFLEX Coil SuiteMr Instruments, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042844 | GE Signa Excite 1.5T 6 Channel Phased Array Flex Coil, GE Signa Excite 3.0T 6… | Ge Medical Systems, Inc. | 2004 | — |
| −1 | K110610 | 1.5 GE 6-Channel Phased Array Flex Coil, 3.0 GE 6-Channel Phased Array Flex Coil | Ge Medical Systems, LLC | 2011 | 1 |
| 0 (this device) | K130706 | Duoflex Coil Suite (1.5T) | Mr Instruments, Inc. | 2013 | — |
| +1 | K173290 | DuoFLEX Coil Suite | Mr Instruments, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K110610 | 1.5 GE 6-Channel Phased Array Flex Coil, 3.0 GE 6-Channel Phased Array Flex CoilSummary page 1…Minnetonka, MN 55343 Establishment Registration: 3003852428 Predicate Device: *GE 1.5T 6-Channel Phased Array Flex Coil (K110610) Page 16 of 79 V.3/11/2013 5:34 PM… | 2011 |
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 |
|---|---|---|---|
| K173290 | DuoFLEX Coil Suite | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 23, 2017 | Class II | Z-3067-2017 | Error in labeling | Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K173290 (Mr Instruments, Inc., 2017) has gone furthest, with 0 descendants of its own.
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 DuoFLEX Coil Suite is indicate for use on the order of the physician in conjunction with a 1.5T MRI scanner, as an accessory to product 2D and 3D images. The DuoFLEX Coil Suite is for use with GE Healthcare MR Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130706 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130706: Duoflex Coil Suite (1.5T).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130706
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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