The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Discovery Model Ct590 Rt And Optima Model Ct580 Ct Systems.
| Device ID | K093581 |
| 510k Number | K093581 |
| Device Name: | DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Tracey Ortiz |
| Correspondent | Tracey Ortiz GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-18 |
| Decision Date | 2011-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682118699 | K093581 | 000 |
| 00840682118552 | K093581 | 000 |
| 00840682102513 | K093581 | 000 |