Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K014022 |
Device Name |
MRI LINE MARKER |
Applicant |
I.Z.I. CORP. |
7020 TUDSBURY RD. |
BALTIMORE,
MD
21244
|
|
Applicant Contact |
HELEN ZINREICH |
Correspondent |
I.Z.I. CORP. |
7020 TUDSBURY RD. |
BALTIMORE,
MD
21244
|
|
Correspondent Contact |
HELEN ZINREICH |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 12/06/2001 |
Decision Date | 03/04/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|