The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Discovery Ct 590 Rt, Optima Ct 580, Optima Ct 580 Rt, Optima Ct 580 W.
| Device ID | K132410 |
| 510k Number | K132410 |
| Device Name: | DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Helen Peng |
| Correspondent | Helen Peng 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 | 2013-08-02 |
| Decision Date | 2014-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682134989 | K132410 | 000 |
| 00840682134972 | K132410 | 000 |
| 00195278303219 | K132410 | 000 |