The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Model Mba-130 Mobile X-ray System.
| Device ID | K862118 |
| 510k Number | K862118 |
| Device Name: | MODEL MBA-130 MOBILE X-RAY SYSTEM |
| Classification | System, X-ray, Mobile |
| Applicant | ELSCINT, INC. 751 EXPRESSWAY DR. Itasca, IL 60143 |
| Contact | Robert E Kenney |
| Correspondent | Robert E Kenney ELSCINT, INC. 751 EXPRESSWAY DR. Itasca, IL 60143 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-03 |
| Decision Date | 1986-06-16 |