The following data is part of a premarket notification filed by Radiation Measurements, Inc. with the FDA for Digi-x.
| Device ID | K834483 |
| 510k Number | K834483 |
| Device Name: | DIGI-X |
| Classification | Instrument, Quality-assurance, Radiologic |
| Applicant | RADIATION MEASUREMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LHO |
| CFR Regulation Number | 892.1940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-06 |
| Decision Date | 1984-03-05 |