| Device Classification Name |
System, Image Processing, Radiological
|
| 510(k) Number |
K961403 |
| Device Name |
LIFE IMAGING SYSTEMS LIS 6000 A |
| Applicant |
| Life Imaging Systems, Inc. |
| 306a Weathervane |
| Office Commons |
|
Richboro,
PA
18954
|
|
| Applicant Contact |
RICHARD DERMAN |
| Correspondent |
| Life Imaging Systems, Inc. |
| 306a Weathervane |
| Office Commons |
|
Richboro,
PA
18954
|
|
| Correspondent Contact |
RICHARD DERMAN |
| Regulation Number | 892.2050 |
| Classification Product Code |
|
| Date Received | 04/11/1996 |
| Decision Date | 07/03/1996 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|