The following data is part of a premarket notification filed by General Electric Co. with the FDA for Discovery St Pet/ct Imaging System With An Alternate Detector Option.
| Device ID | K042257 |
| 510k Number | K042257 |
| Device Name: | DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION |
| 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 | 2004-08-20 |
| Decision Date | 2004-09-08 |
| Summary: | summary |