Device Classification Name |
Coil, Magnetic Resonance, Specialty
|
510(k) Number |
K211658 |
Device Name |
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 |
Applicant |
NORAS MRI products GmbH |
Leibnizstr. 4 |
Hoechberg,
DE
97204
|
|
Applicant Contact |
Manuel Noras |
Correspondent |
NORAS MRI products GmbH |
Leibnizstr. 4 |
Hoechberg,
DE
97204
|
|
Correspondent Contact |
Patricia Kirchner |
Regulation Number | 892.1000
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/28/2021 |
Decision Date | 03/03/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|