| Device Classification Name |
Bed, Scanning, Nuclear
|
| 510(k) Number |
K893826 |
| Device Name |
QRSYSTEMS H.D. NUCLEAR IMAGING TABLE |
| Applicant |
| Qrsystems, Inc. |
| P.O. Box 380781 |
|
San Antonio,
TX
78280
|
|
| Applicant Contact |
GLENN SMITH |
| Correspondent |
| Qrsystems, Inc. |
| P.O. Box 380781 |
|
San Antonio,
TX
78280
|
|
| Correspondent Contact |
GLENN SMITH |
| Regulation Number | 892.1350 |
| Classification Product Code |
|
| Date Received | 05/24/1989 |
| Decision Date | 08/02/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|