The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ct Coronary Artery Calcification Scoring (cacs) Option For Advantage Windows.
| Device ID | K982004 |
| 510k Number | K982004 |
| Device Name: | CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-08 |
| Decision Date | 1998-08-18 |
| Summary: | summary |