INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS


Device Classification Name

accelerator, linear, medical

510(k) Number K072454
Device Name INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS
Applicant
INTEGRA RADIONICS, INC.
22 terry avenue
burlington, 
MA 
01803

Applicant Contact kevin j o’connell
Correspondent
INTEGRA RADIONICS, INC.
22 terry avenue
burlington, 
MA 
01803

Correspodent Contact kevin j o’connell
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 08/31/2007
Decision Date 10/16/2007
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