The following data is part of a premarket notification filed by Cgr Medical Corp. with the FDA for Maximax - 4.
| Device ID | K841649 |
| 510k Number | K841649 |
| Device Name: | MAXIMAX - 4 |
| Classification | Programmer, Changer, Film/cassette, Radiographic |
| Applicant | CGR MEDICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IZP |
| CFR Regulation Number | 892.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-20 |
| Decision Date | 1984-06-05 |