510(k) · Cleared
ClearedMedrad 1.5T Peripheral Vascular Array
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medrad, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jan 27, 1998 after a 71-day review. The FDA summary names its predicate without a number.
- Decided
- Jan 27, 1998
- Review
- 71 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | GE Signa 1.5T Body Coil Named without a submission number |
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.
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 Peripheral Vascular Array is a phased array device which operates in the receive-only mode. The device is intended to receive signal from hydrogen protons during MR imaging. The Peripheral Vascular Array, as with any surface coil utilized in MR imaging, is intended to provide improved image quality as a result of the high Signal to Noise ratio (SNR) produced when placing a surface coil close to the anatomy of interest. Higher SNR allows the user to…
Read the full statement (187 words)
The Peripheral Vascular Array is a phased array device which operates in the receive-only mode. The device is intended to receive signal from hydrogen protons during MR imaging. The Peripheral Vascular Array, as with any surface coil utilized in MR imaging, is intended to provide improved image quality as a result of the high Signal to Noise ratio (SNR) produced when placing a surface coil close to the anatomy of interest. Higher SNR allows the user to prescribe thinner slices and higher matrices necessary for the high spatial resolution needed in making diagnosis.
The Peripheral Vascular Array is primarily designed for imaging of the vascular structures of the abdomen, pelvis, and lower limbs. Soft tissue imaging of these areas may also be evaluated using this device. The design of this coil allows the user to easily image the large peripheral vascular system associated with the abdomen, pelvis and lower limbs without moving the patient of the coil.
Patient fitness and suitability to undergo an MRI exam utilizing the Peripheral Vascular Array must be determined by the individual physician trained in the field of Diagnostic Magnetic Resonance Imaging.
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/K974308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974308: Medrad 1.5T Peripheral Vascular Array.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974308
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026