The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Ax Workstation.
Device ID | K992073 |
510k Number | K992073 |
Device Name: | AX WORKSTATION |
Classification | System, Image Processing, Radiological |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 2501 NORTH BARRINGTON RD. Hoffman Estates, IL 60195 -7372 |
Contact | Robert W Callahan |
Correspondent | Robert W Callahan SIEMENS MEDICAL SOLUTIONS USA, INC. 2501 NORTH BARRINGTON RD. Hoffman Estates, IL 60195 -7372 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-06-18 |
Decision Date | 1999-09-09 |
Summary: | summary |