ECG CT Gating Device— 510(k) K160350
Substantially EquivalentNeocoil, LLC
FDA 510(k) clearance K160350 for ECG CT Gating Device, Substantially Equivalent on 2016-06-16. Applicant: Neocoil, LLC. Device class: 2.
Clearance details
- Applicant
- Neocoil, LLC
- Product code
- Code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pewaukee, WI, US
Recent devices under product code JAK
view allMore clearances from Neocoil, LLC
view all- K260947 — 0.55T 12Ch Breast Coil
- K222407 — 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil
- K213687 — 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch
- K201101 — 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil
- K182958 — 1.5T 16ch Breast Coil
Adverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.