The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Rtp-5000.
| Device ID | K813439 |
| 510k Number | K813439 |
| Device Name: | RTP-5000 |
| Classification | System, Therapeutic, X-ray |
| Applicant | ADAC LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JAD |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-08 |
| Decision Date | 1982-01-22 |