The following data is part of a premarket notification filed by Image Systems, Inc. with the FDA for Sciview System, Model Sc1250 And Pixie Imaging Sof.
| Device ID | K901422 |
| 510k Number | K901422 |
| Device Name: | SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF |
| Classification | System, Image Processing, Radiological |
| Applicant | IMAGE SYSTEMS, INC. CONSULTANT 16303 PANORAMIC WAY San Leandro, CA 94578 |
| Contact | J Allsebrook |
| Correspondent | 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 | 1990-03-26 |
| Decision Date | 1990-08-21 |