| 510(k) Number |
K827377 |
| Device Name |
MODEL LS 3000 LINEAR SCANNER |
| Applicant |
| Hitachi Medical Corp. |
| No 1-1-14 Uchikand Chiyoda Ku |
|
Tokyo,
JP
|
|
| Correspondent |
| Hitachi Medical Corp. |
| No 1-1-14 Uchikand Chiyoda Ku |
|
Tokyo,
JP
|
|
| Date Received | 04/20/1982 |
| Decision Date | 07/13/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|