The following data is part of a premarket notification filed by Acuson Corp. with the FDA for Kinetdx Picture Archiving And Communications System.
| Device ID | K023772 |
| 510k Number | K023772 |
| Device Name: | KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | ACUSON CORP. 1230 SHOREBIRD WAY Mountain View, CA 94043 |
| Contact | Bob Leiker |
| Correspondent | Mark Job TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-11-12 |
| Decision Date | 2002-11-22 |
| Summary: | summary |