The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Isorex Ls-36.
| Device ID | K834496 |
| 510k Number | K834496 |
| Device Name: | ISOREX LS-36 |
| Classification | System, X-ray, Angiographic |
| Applicant | ELSCINT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-08 |
| Decision Date | 1984-02-21 |