The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Digitilt Ls-30 Remote Control.
| Device ID | K834288 |
| 510k Number | K834288 |
| Device Name: | DIGITILT LS-30 REMOTE CONTROL |
| Classification | System, X-ray, Tomographic |
| Applicant | ELSCINT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IZF |
| CFR Regulation Number | 892.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-28 |
| Decision Date | 1983-12-29 |