510(k) · Cleared
ClearedPhased Array Flexible Cardiac Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Feb 8, 1999 as substantially equivalent to K962117 (Philips Medical Systems (Cleveland), Inc., 1996) after a 46-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Feb 8, 1999
- Review
- 46 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954190 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK954190 Model 580GE-64 Quadrature Abdominal Flex CoilMedical Advances, Inc. · 1995
- 1 generation backK962117 Quadrature and Phased Array Flexible Body CoilsPhilips Medical Systems (Cleveland), Inc. · 1996
- This deviceK984588 Phased Array Flexible Cardiac CoilPhilips Medical Systems (Cleveland), Inc. · 1999
- Descendant · cites it directly · 0 of its ownK031095 Sense Body CoilPhilips Medical Systems (Cleveland), Inc. · 2003
Most influential descendants
Showing 1 of 1 · See all- K031095Sense Body CoilPhilips Medical Systems (Cleveland), Inc. · 2003 · 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 | K962117 | Quadrature and Phased Array Flexible Body Coils | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| 0 (this device) | K984588 | Phased Array Flexible Cardiac Coil | Philips Medical Systems (Cleveland), Inc. | 1999 | — |
| +1 | K031095 | Sense Body Coil | Philips Medical Systems (Cleveland), Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 |
|---|---|---|---|
| * | K962117 | Quadrature and Phased Array Flexible Body CoilsSummary page 2…of the standard body coil. 4. Safety and Effectiveness The Picker Phased Array Cardiac Coil is substantially equivalent to the Picker Phased Array Flexible Body Coil (K962117) in safety and effectiveness. The following chart has been compiled to demonstrate this equivalence. Predicate Device: Phased Ar… | 1996 |
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 |
|---|---|---|---|
| K031095 | Sense Body Coil | 2003 | 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 4 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K031095 (Philips Medical Systems (Cleveland), Inc., 2003) 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.
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 Phased Array Flexible Cardiac Coil does not change the intended use of the Picker 1.5T EDGE ECLIPSE system. The 1.5T EDGE ECLIPSE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole…
Read the full statement (128 words)
The Phased Array Flexible Cardiac Coil does not change the intended use of the Picker 1.5T
EDGE ECLIPSE system.
The 1.5T EDGE ECLIPSE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The Phased Array Flexible Cardiac Coil is indicated for use in the following anatomic regions and with the designated nuclei:
Anatomic Regions: Heart and associated structures in the thoracic region.
Nuclei Excited: Hydrogen.
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/K984588 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984588: Phased Array Flexible Cardiac Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984588
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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