510(k) · Cleared
ClearedPhased Array Neck 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 11, 1997 as substantially equivalent to K945827 (Philips Medical Systems (Cleveland), Inc., 1995) and 1 other predicate after an 82-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Feb 11, 1997
- Review
- 82 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K925987 (1993). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK925987 Instrumentarium MEGA4 HTInstrumentarium Imaging, Inc. · 1993
- This deviceK964678 Phased Array Neck CoilPhilips Medical Systems (Cleveland), Inc. · 1997
- Descendant · cites it directly · 0 of its ownK981959 Outlook Large Phased Array Neck CoilPhilips Medical Systems (Cleveland), Inc. · 1998
Most influential descendants
Showing 1 of 1 · See all- K981959Outlook Large Phased Array Neck CoilPhilips Medical Systems (Cleveland), Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925987 | Instrumentarium MEGA4 HT | Instrumentarium Imaging, Inc. | 1993 | — |
| 0 (this device) | K964678 | Phased Array Neck Coil | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| +1 | K981959 | Outlook Large Phased Array Neck Coil | Philips Medical Systems (Cleveland), Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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? (2)
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 |
|---|---|---|---|
| * | K945827 | OutlookSummary page 2…ered by ABS and polycarbonate enclosures. Safety and Effectiveness SUBSTANTIAL EQUIVALENCE CHART PARAMETER PHASED ARRAY NECK PREDICATE DEVICE CotL Vascular Head Coil (K945827) & Multipurpose size M Coil (K925987) Enclosure Matenal ABS and Polycarbonate Polyurethane Coil Design Same Two-channel receive-o… | 1995 |
| * | K925987 | Instrumentarium MEGA4 HTSummary page 2…res. Safety and Effectiveness SUBSTANTIAL EQUIVALENCE CHART PARAMETER PHASED ARRAY NECK PREDICATE DEVICE CotL Vascular Head Coil (K945827) & Multipurpose size M Coil (K925987) Enclosure Matenal ABS and Polycarbonate Polyurethane Coil Design Same Two-channel receive-only phased array coil. Decoupling Sam… | 1993 |
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 |
|---|---|---|---|
| K981959 | Outlook Large Phased Array Neck Coil | 1998 | 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?
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?
Neck, from the cerebellum to the upper thoracic spine region.
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/K964678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964678: Phased Array Neck Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964678
Report an extraction error
Are you the manufacturer?
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