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3T 6CH Carotid Coil
NEOCOIL, LLC · Model 01 · UDI-DI 00856181003015
MOS
Prescription
1
510(k) clearances
136
Adverse events
38
Recalls
77
Facilities
Description
The NeoCoil 3.OT 6-Channel Carotid Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the carotid arteries and associated vasculature from the sternal notch through the internal carotid arteries at the level of cervical vertebrae C1 in Magnetic Resonance Imaging Systems. Compared to predicate devices, the submitted device offers greater SNR due to its operating field strength of 3.0T, and a larger field-of-view due to the antenna layout.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-04 | Philips North America Llc | Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 | Philips North America Llc | Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 | Philips North America Llc | Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 | Philips North America Llc | Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 | Philips North America Llc | Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 | Philips North America Llc | Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 | Philips North America Llc | Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 | Philips North America Llc | Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 | Philips North America Llc | Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 | Philips North America Llc | Potential safety issue where a patient may be harmed while preparing for or during a scan. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.