Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K000359 |
Device Name |
EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO |
Applicant |
IMATRON, INC. |
389 OYSTER POINT BLVD. |
SOUTH SAN FRANCISCO,
CA
94080
|
|
Applicant Contact |
J.A. CODUTO |
Correspondent |
IMATRON, INC. |
389 OYSTER POINT BLVD. |
SOUTH SAN FRANCISCO,
CA
94080
|
|
Correspondent Contact |
J.A. CODUTO |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 02/04/2000 |
Decision Date | 03/17/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|