Device Classification Name |
System, Planning, Radiation Therapy Treatment
|
510(k) Number |
K992864 |
Device Name |
RENDER-PLAN 3-D |
Applicant |
PRECISION THERAPY INTL., INC. |
3155 NORTHWOODS PKWY. N.W. |
NORCROSS,
GA
30071
|
|
Applicant Contact |
PAUL SUMMER |
Correspondent |
PRECISION THERAPY INTL., INC. |
3155 NORTHWOODS PKWY. N.W. |
NORCROSS,
GA
30071
|
|
Correspondent Contact |
PAUL SUMMER |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 08/25/1999 |
Decision Date | 09/09/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|