The following data is part of a premarket notification filed by Acoma Medical Imaging, Inc. with the FDA for Futurus 2001 X-ray Generator.
| Device ID | K902637 |
| 510k Number | K902637 |
| Device Name: | FUTURUS 2001 X-RAY GENERATOR |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling, IL 60090 |
| Contact | Jack James |
| Correspondent | Jack James ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling, IL 60090 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-14 |
| Decision Date | 1990-08-03 |