The following data is part of a premarket notification filed by G.d. Searle And Co. with the FDA for Pho. Trax Model 4000 Whole Body Scan..
| Device ID | K760808 |
| 510k Number | K760808 |
| Device Name: | PHO. TRAX MODEL 4000 WHOLE BODY SCAN. |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | G.D. SEARLE AND CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-10-12 |
| Decision Date | 1976-11-05 |