| Device Classification Name |
System, Imaging, Pulsed Echo, Ultrasonic
|
| 510(k) Number |
K924458 |
| Device Name |
AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZ |
| Applicant |
| Acoustic Imaging Technologies Corp. |
| 10027 S. 15st St. |
|
Phoenix,
AZ
85044
|
|
| Applicant Contact |
MICHAEL A PARSONS |
| Correspondent |
| Acoustic Imaging Technologies Corp. |
| 10027 S. 15st St. |
|
Phoenix,
AZ
85044
|
|
| Correspondent Contact |
MICHAEL A PARSONS |
| Regulation Number | 892.1560 |
| Classification Product Code |
|
| Date Received | 09/02/1992 |
| Decision Date | 01/21/1993 |
| 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
|
|
|