The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Volumax Ct Imaging System.
| Device ID | K982060 |
| 510k Number | K982060 |
| Device Name: | VOLUMAX CT IMAGING SYSTEM |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | ELSCINT, INC. 22 PARIS AVE. Rockleigh, NJ 07647 |
| Contact | Steven M Kay |
| Correspondent | Steven M Kay ELSCINT, INC. 22 PARIS AVE. Rockleigh, NJ 07647 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-11 |
| Decision Date | 1998-09-02 |
| Summary: | summary |