The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Fan Beam Collimator.
Device ID | K933256 |
510k Number | K933256 |
Device Name: | FAN BEAM COLLIMATOR |
Classification | Camera, Scintillation (gamma) |
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 | IYX |
CFR Regulation Number | 892.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-06 |
Decision Date | 1993-10-29 |