The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Ct Scope.
| Device ID | K974344 |
| 510k Number | K974344 |
| Device Name: | CT SCOPE |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | ELSCINT, INC. 86 ORCHARD ST. Hackensack, NJ 07601 |
| Contact | Steven Kay |
| Correspondent | Steven Kay ELSCINT, INC. 86 ORCHARD ST. Hackensack, NJ 07601 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-19 |
| Decision Date | 1998-06-03 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CT SCOPE 75440543 2302782 Dead/Cancelled |
VARCO I/P, INC. 1998-02-25 |