The following data is part of a premarket notification filed by Accuimage Diagnostics Corp. with the FDA for Accuimage, Accuview Diagnostic Imaging, Workstation W/accuscore, Accuanalyze, Accuscope, Accushade, Accuvrt, And Accumip.
| Device ID | K990241 |
| 510k Number | K990241 |
| Device Name: | ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE, ACCUSCOPE, ACCUSHADE, ACCUVRT, AND ACCUMIP |
| Classification | System, Image Processing, Radiological |
| 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 | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-25 |
| Decision Date | 1999-09-23 |
| Summary: | summary |