The following data is part of a premarket notification filed by Cgr Medical Corp. with the FDA for Process 100 St.
| Device ID | K833846 |
| 510k Number | K833846 |
| Device Name: | PROCESS 100 ST |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | CGR MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-15 |
| Decision Date | 1983-12-16 |