510(k) · Cleared
ClearedSigna 1.5T Phosphorus (P) Transmit/Receive Flex Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · MOS Coil, Magnetic Resonance, Specialty
Cleared on Feb 19, 1999 as substantially equivalent to K962061 (GE Medical Systems, 1996) and 2 other predicates after a 164-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Feb 19, 1999
- Review
- 164 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K923264 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK923264 General Purpose Flex CoilGeneral Electric Co. · 1992
- This deviceK983139 Signa 1.5T Phosphorus (P) Transmit/Receive Flex CoilGE Medical Systems · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923264 | General Purpose Flex Coil | General Electric Co. | 1992 | — |
| 0 (this device) | K983139 | Signa 1.5T Phosphorus (P) Transmit/Receive Flex Coil | GE Medical Systems | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 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? (3)
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 |
|---|---|---|---|
| * | K962061 | Magnetic Resonance Diagnostic SystemSummary page 1…® 1.5T Phosphorus (*'P) Transmit/Receive Flex Coil is substantially equivalent to the currently marketed products: o Signa® 1.5T Magnetic Resonance System; 510(k) Number K962061 This submission cleared the MR system for imaging. e Hydrogen Spectroscopy Accessory - Probe; 510(k) Number K930265 This submiss… | 1996 |
| * | K930265 | Hydrogen Spectroscopy Option-Probe #M1040HS/HTSummary page 1…Signa® 1.5T Magnetic Resonance System; 510(k) Number K962061 This submission cleared the MR system for imaging. e Hydrogen Spectroscopy Accessory - Probe; 510(k) Number K930265 This submission cleared the option for the MR system to produce localized spectra that display the internal biochemical character… | 1995 |
| * | K923264 | General Purpose Flex CoilSummary page 1…ption for the MR system to produce localized spectra that display the internal biochemical characteristics of the human body. e General Purpose Flex Coil; 510(k) Number K923264 This submission cleared the use of the flex coil within the MR system as an option for the purpose of improving the signal-to-noi… | 1992 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K962061.
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 Signa® 1.5T Phosphorus (*'P) Transmit/Receive Flex Coil is intended to
operate with the Signa® 1.5T Magnetic Resonance System. The coil is simply to
improve the signal-to-noise performance of the MR system in specific anatomical
areas.
The Signa® 1.5T Phosphorus (*'P) Transmit/Receive Flex Coil is intended for
general diagnostic use to present magnetic resonance spectra which reflect
frequency and distribution of nuclei exhibiting nuclear magnetic resonance of
phosphorus (*'P) spectra.
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/K983139 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983139: Signa 1.5T Phosphorus (P) Transmit/Receive Flex Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983139
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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