Last synced on 12 July 2024 at 11:04 pm

OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211658
510(k) Type
Traditional
Applicant
NORAS MRI products GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
3/3/2022
Days to Decision
279 days
Submission Type
Summary

OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211658
510(k) Type
Traditional
Applicant
NORAS MRI products GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
3/3/2022
Days to Decision
279 days
Submission Type
Summary