Last synced on 7 June 2024 at 11:04 pm

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213687
510(k) Type
Traditional
Applicant
NeoCoil, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/11/2022
Days to Decision
108 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213687
510(k) Type
Traditional
Applicant
NeoCoil, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/11/2022
Days to Decision
108 days
Submission Type
Summary