Device Classification Name |
Couch, Radiation Therapy, Powered
|
510(k) Number |
K983678 |
Device Name |
ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE |
Applicant |
ELEKTA INSTRUMENTS, INC. |
3155 NORTHWOODS PKWY. N.W. |
NORCROSS,
GA
30071
|
|
Applicant Contact |
PAUL L SUMNER |
Correspondent |
ELEKTA INSTRUMENTS, INC. |
3155 NORTHWOODS PKWY. N.W. |
NORCROSS,
GA
30071
|
|
Correspondent Contact |
PAUL L SUMNER |
Regulation Number | 892.5770
|
Classification Product Code |
|
Date Received | 10/20/1998 |
Decision Date | 01/15/1999 |
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
|
|
|