The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Ax Workstation Dr-viewer Software Option.
Device ID | K992925 |
510k Number | K992925 |
Device Name: | AX WORKSTATION DR-VIEWER SOFTWARE OPTION |
Classification | System, Image Processing, Radiological |
Applicant | SIEMENS CORP. 186 WOOD AVE., SOUTH Iselin, NJ 08830 |
Contact | Kathleen Rutherford |
Correspondent | Kathleen Rutherford SIEMENS CORP. 186 WOOD AVE., SOUTH Iselin, NJ 08830 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-30 |
Decision Date | 1999-11-23 |
Summary: | summary |