SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0


Device Classification Name

system,planning,radiation therapy treatment

510(k) Number K992303
Device Name SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0
Applicant
NUCLETRON CORP.
7080 columbia gateway dr.
columbia, 
MD 
21046

Applicant Contact ralph e shuping
Correspondent
NUCLETRON CORP.
7080 columbia gateway dr.
columbia, 
MD 
21046

Correspodent Contact ralph e shuping
Regulation Number 892.5050
Classification Product Code
MUJ  
Date Received 07/08/1999
Decision Date 03/27/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No