The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Optima Ct660.
| Device ID | K131576 |
| 510k Number | K131576 |
| Device Name: | OPTIMA CT660 |
| 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 | 2013-05-31 |
| Decision Date | 2013-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682116510 | K131576 | 000 |
| 00840682109796 | K131576 | 000 |