510(k) K042257 ยท KPS System, Tomography, Computed, Emission
DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION
| Applicant | General Electric Co., Milwaukee WI, US |
| Decision | Substantially Equivalent, Sep 8, 2004 |
| Received | Aug 20, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042257
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2006 | General Electric Med Systems LLC Discovery ST PET/CT imaging system with gantry model number 5105797. Catalog Identifiers: S9114LA/LB/MA/MN, S9118LA/LB/MA/MN, S9116LA/MA. The system combines the high performance Lightspeed Plus CT Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.