| Device Classification Name |
Accelerator, Linear, Medical
|
| 510(k) Number |
K090044 |
| Device Name |
PATLOG, PATLOG PATIENT HANDLING SYSTEM, PATLOG TOPLOG TABLE TOP, MODEL(S) 1.0, 1.0, C |
| Applicant |
| Oncolog Medical QA AB |
| Vallvagen 4b |
|
Uppsala,
SE
756 51
|
|
| Applicant Contact |
JAN TORNQVIST |
| Correspondent |
| Underwriters Laboratories, Inc. |
| 1285 Walt Whitman Rd. |
|
Melville,
NY
11747
|
|
| Correspondent Contact |
CASEY CONRY |
| Regulation Number | 892.5050 |
| Classification Product Code |
|
| Date Received | 01/07/2009 |
| Decision Date | 01/22/2009 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
Yes
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|