The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Sienet Camera Server.
Device ID | K923582 |
510k Number | K923582 |
Device Name: | SIENET CAMERA SERVER |
Classification | System, Digital Image Communications, Radiological |
Applicant | SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates, IL 60195 -7372 |
Contact | Irena Krutulis |
Correspondent | Irena Krutulis SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates, IL 60195 -7372 |
Product Code | LMD |
CFR Regulation Number | 892.2020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-20 |
Decision Date | 1992-10-14 |