DILON 6800 ACELLA (ACELLA)


Device Classification Name

camera, scintillation (gamma)

510(k) Number K110384
Device Name DILON 6800 ACELLA (ACELLA)
Applicant
DILON TECHNOLOGIES, INC.
p.o. box 560
stillwater, 
MN 
55082

Applicant Contact elaine duncan
Correspondent
DILON TECHNOLOGIES, INC.
p.o. box 560
stillwater, 
MN 
55082

Correspodent Contact elaine duncan
Regulation Number 892.1100
Classification Product Code
IYX  
Date Received 02/10/2011
Decision Date 05/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No