The following data is part of a premarket notification filed by Ge Medical Systems F.i. Haifa with the FDA for Infinia Lightspeed.
| Device ID | K043381 |
| 510k Number | K043381 |
| Device Name: | INFINIA LIGHTSPEED |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE MEDICAL SYSTEMS F.I. HAIFA 4 HAYOZMA ST. Tirat Hacarmel, IL 30200 |
| Contact | Laurence Bigio |
| Correspondent | Alex Grob 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 | 2004-12-09 |
| Decision Date | 2004-12-23 |
| Summary: | summary |