The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Siemens Pacs/1-b (optical Disk Option).
Device ID | K884995 |
510k Number | K884995 |
Device Name: | SIEMENS PACS/1-B (OPTICAL DISK OPTION) |
Classification | System, Image Processing, Radiological |
Applicant | SIEMENS GAMMASONICS, INC. 2000 NUCLEAR DR. Des Plaines, IL 60018 |
Contact | Merribeth Adams |
Correspondent | Merribeth Adams SIEMENS GAMMASONICS, INC. 2000 NUCLEAR DR. Des Plaines, IL 60018 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-12-01 |
Decision Date | 1989-02-28 |