The following data is part of a premarket notification filed by Acuson Corp. with the FDA for Csv12 Software Viewer.
Device ID | K022896 |
510k Number | K022896 |
Device Name: | CSV12 SOFTWARE VIEWER |
Classification | System, Image Processing, Radiological |
Applicant | ACUSON CORP. 1220 CHARLESTON RD. Mountain View, CA 94039 -7393 |
Contact | Bob Leiker |
Correspondent | Bob Leiker ACUSON CORP. 1220 CHARLESTON RD. Mountain View, CA 94039 -7393 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-09-03 |
Decision Date | 2002-10-03 |
Summary: | summary |