The following data is part of a premarket notification filed by Accuimage Diagnostics Corp. with the FDA for Accuimage Smartgate Upgrade.
| Device ID | K012106 |
| 510k Number | K012106 |
| Device Name: | ACCUIMAGE SMARTGATE UPGRADE |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | ACCUIMAGE DIAGNOSTICS CORP. 16303 PANORAMIC WAY San Leandro, CA 94578 -1116 |
| Contact | Gary J Allsebrook |
| Correspondent | Gary J Allsebrook ACCUIMAGE DIAGNOSTICS CORP. 16303 PANORAMIC WAY San Leandro, CA 94578 -1116 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-06 |
| Decision Date | 2001-09-25 |
| Summary: | summary |