The following data is part of a premarket notification filed by Image Systems, Inc. with the FDA for Statview.
| Device ID | K913755 |
| 510k Number | K913755 |
| Device Name: | STATVIEW |
| Classification | System, Image Processing, Radiological |
| Applicant | IMAGE SYSTEMS, INC. CONSULTANT 16303 PANORAMIC WAY San Leandro, CA 94578 |
| Contact | Gary J Allsebrook |
| Correspondent | Gary J Allsebrook IMAGE SYSTEMS, INC. CONSULTANT 16303 PANORAMIC WAY San Leandro, CA 94578 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-21 |
| Decision Date | 1991-11-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() STATVIEW 75398335 2789020 Dead/Cancelled |
GENERAL ELECTRIC COMPANY 1997-12-01 |
![]() STATVIEW 73662692 1499287 Dead/Cancelled |
ABACUS CONCEPTS, INC. 1987-05-26 |