HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL


Device Classification Name

system, tomography, computed, emission

510(k) Number K991129
Device Name HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL
Applicant
HITACHI MEDICAL CORP. OF AMERICA
9177 dutton dr.
twinsburg, 
OH 
44056

Applicant Contact gary w enos
Correspondent
HITACHI MEDICAL CORP. OF AMERICA
9177 dutton dr.
twinsburg, 
OH 
44056

Correspodent Contact gary w enos
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 04/02/1999
Decision Date 05/13/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No