The following data is part of a premarket notification filed by Acoma Medical Imaging, Inc. with the FDA for Scd-105 And Scd-125 Capacitor Discharge Mobile X-r.
| Device ID | K921425 |
| 510k Number | K921425 |
| Device Name: | SCD-105 AND SCD-125 CAPACITOR DISCHARGE MOBILE X-R |
| Classification | System, X-ray, Mobile |
| Applicant | ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling, IL 60090 |
| Contact | James L Lambrecht |
| Correspondent | James L Lambrecht ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling, IL 60090 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-24 |
| Decision Date | 1992-08-27 |