The following data is part of a premarket notification filed by Medical Imaging Technologies, Inc. with the FDA for Imac2000.
| Device ID | K911764 |
| 510k Number | K911764 |
| Device Name: | IMAC2000 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | MEDICAL IMAGING TECHNOLOGIES, INC. 106 WEST WALNUT ST. Lakeland, FL 33801 |
| Contact | C. H Moore |
| Correspondent | C. H Moore MEDICAL IMAGING TECHNOLOGIES, INC. 106 WEST WALNUT ST. Lakeland, FL 33801 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-19 |
| Decision Date | 1991-09-23 |