The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Smartview Options For Hispeed Ct/i.
| Device ID | K973168 |
| 510k Number | K973168 |
| Device Name: | SMARTVIEW OPTIONS FOR HISPEED CT/I |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS 16800 RYERSON RD. New Berlin, WI 53151 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS 16800 RYERSON RD. New Berlin, WI 53151 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-25 |
| Decision Date | 1997-11-21 |
| Summary: | summary |