The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Ct Colonography/navigator2.
| Device ID | K012313 |
| 510k Number | K012313 |
| Device Name: | CT COLONOGRAPHY/NAVIGATOR2 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry Kroger |
| Correspondent | Reiner Krumme TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-07-23 |
| Decision Date | 2001-08-07 |
| Summary: | summary |