Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K180901 |
Device Name |
Low Dose CT Lung Cancer Screening Option |
Applicant |
Hitachi Healthcare Americas |
1959 Summit Commerce Park |
Twinsburg,
OH
44087
|
|
Applicant Contact |
Doug Thistlethwaite |
Correspondent |
Hitachi Healthcare Americas |
1959 Summit Commerce Park |
Twinsburg,
OH
44087
|
|
Correspondent Contact |
Doug Thistlethwaite |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 04/06/2018 |
Decision Date | 05/16/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|