The following data is part of a premarket notification filed by Rad-source, Inc. with the FDA for Shielded Cabinet X-ray Radiation Source Device Model Rs 3000.
| Device ID | K974210 |
| 510k Number | K974210 |
| Device Name: | SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 |
| Classification | Irradiator, Blood To Prevent Graft Versus Host Disease |
| Applicant | RAD-SOURCE, INC. 475 RAMBLEWOOD DR., SUITE 207 Coral Springs, FL 33071 |
| Contact | Randol E Kirk |
| Correspondent | Randol E Kirk RAD-SOURCE, INC. 475 RAMBLEWOOD DR., SUITE 207 Coral Springs, FL 33071 |
| Product Code | MOT |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-10 |
| Decision Date | 1998-03-30 |
| Summary: | summary |