The following data is part of a premarket notification filed by Cgr Medical Corp. with the FDA for Ct Scanner Nd 8000.
| Device ID | K781040 |
| 510k Number | K781040 |
| Device Name: | CT SCANNER ND 8000 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | CGR MEDICAL CORP. 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 | 1978-06-20 |
| Decision Date | 1978-07-18 |