The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Smartscore 3.5; Smartscore 4.0; Smartscore 4.5.
| Device ID | K020929 |
| 510k Number | K020929 |
| Device Name: | SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS 283 RUE DE LA MINIERE BP 34 Buc Cedex, FR 78533 |
| Correspondent | Wolfram Gmelin 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 | 2002-03-22 |
| Decision Date | 2002-04-03 |
| Summary: | summary |