The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Mobile Discovery St Pet Ct Imaging System.
Device ID | K030199 |
510k Number | K030199 |
Device Name: | GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM |
Classification | System, Tomography, Computed, Emission |
Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
Contact | David Duersteler |
Correspondent | David Duersteler GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
Product Code | KPS |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-01-21 |
Decision Date | 2003-02-11 |
Summary: | summary |