Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K211663 |
Device Name |
Zap-X Radiosurgical System |
Applicant |
Zap Surgical Systems, Inc. |
590 Taylor Way |
San Carlos,
CA
94070
|
|
Applicant Contact |
Jim Talbot |
Correspondent |
Zap Surgical Systems, Inc. |
590 Taylor Way |
San Carlos,
CA
94070
|
|
Correspondent Contact |
Jim Talbot |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 06/01/2021 |
Decision Date | 07/29/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|