510(k) · Cleared
Cleared1.5T and 3T 8-Channel Medium General Purpose Flex Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invivo Corporation · MOS Coil, Magnetic Resonance, Specialty
Cleared on Dec 23, 2011 as substantially equivalent to K093842 (Invivo Corporation, 2010) after a 191-day review. Its family tree reaches back 2 generations to 1995. 5 later devices descend from it.
- Decided
- Dec 23, 2011
- Review
- 191 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954190 (1995). 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK954190 Model 580GE-64 Quadrature Abdominal Flex CoilMedical Advances, Inc. · 1995
- 1 generation backK093842 1.5T and 3.0T General Purpose Flex CoilsInvivo Corporation · 2010
- This deviceK111673 1.5T and 3T 8-Channel Medium General Purpose Flex CoilInvivo Corporation · 2011
- Descendant · cites it directly · 3 of its ownK120122 Sense MSK S 8CH 1.5TInvivo Corporation · 2012
- Descendant · cites it directly · 2 of its ownK212864 dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5TPhilips Healthcare (Suzhou) Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK232021 Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TPhilips Healthcare (Suzhou) Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK260519 Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK140252 16 CH Multipurpose Coil VarietyNoras Rontgen-Und Medizintechnik GmbH · 2014
Most influential descendants
Showing 5 of 5 · See all- K120122Sense MSK S 8CH 1.5TInvivo Corporation · 2012 · cites it directly3descendants
- K212864dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5TPhilips Healthcare (Suzhou) Co., Ltd. · 2021 · cites it directly2descendants
- K232021Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TPhilips Healthcare (Suzhou) Co., Ltd. · 2023 · 2 generations on1descendant
- K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd. · 2026 · 3 generations on0descendants
- K14025216 CH Multipurpose Coil VarietyNoras Rontgen-Und Medizintechnik GmbH · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954190 | Model 580GE-64 Quadrature Abdominal Flex Coil | Medical Advances, Inc. | 1995 | — |
| −1 | K093842 | 1.5T and 3.0T General Purpose Flex Coils | Invivo Corporation | 2010 | — |
| 0 (this device) | K111673 | 1.5T and 3T 8-Channel Medium General Purpose Flex Coil | Invivo Corporation | 2011 | — |
| +1 | K120122 | Sense MSK S 8CH 1.5T | Invivo Corporation | 2012 | — |
| +1 | K212864 | dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | 2021 | — |
| +2 | K232021 | Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | 2023 | — |
| +3 | K260519 | Smart Fit TorsoCardiac 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | 2026 | — |
| +1 | K140252 | 16 CH Multipurpose Coil Variety | Noras Rontgen-Und Medizintechnik GmbH | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K093842 | 1.5T and 3.0T General Purpose Flex CoilsSummary page 1…rom the predicate devices. Substantial Equivalence Information: When compared to the predicate devices, I1.5T and 3.0T 8-channel General Purpose Flex Coil - K<093842, cleared 3/5/10, substantial equivalence is based on similarities in design features, overall indications for use, and… | 2010 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 2 companies; a new generation was cleared every 14.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K120122 (Invivo Corporation, 2012) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K093842.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 coil is indicated for use on the order of a physician, in conjunction with Philips 1.5T and 31ff MR scanners as an accessory to produce images, as an aid to diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111673 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111673: 1.5T and 3T 8-Channel Medium General Purpose Flex Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111673
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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