The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Optima Nm/ct 640.
| Device ID | K121019 |
| 510k Number | K121019 |
| Device Name: | OPTIMA NM/CT 640 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE HEALTHCARE 4 HAYOZMA STREET Tirat Hacarmel, IL 30200 |
| Contact | Eli Werner |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-04-04 |
| Decision Date | 2012-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682139281 | K121019 | 000 |
| 00840682123730 | K121019 | 000 |
| 00840682115285 | K121019 | 000 |