The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Litebox Diagnostic Review Workstation.
Device ID | K901158 |
510k Number | K901158 |
Device Name: | LITEBOX DIAGNOSTIC REVIEW WORKSTATION |
Classification | System, Image Processing, Radiological |
Applicant | SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates, IL 60195 -7372 |
Contact | Dennis W Henkelman |
Correspondent | Dennis W Henkelman SIEMENS GAMMASONICS, INC. 2501 N. 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 | 1990-03-13 |
Decision Date | 1990-04-19 |