The following data is part of a premarket notification filed by Ziosoft, Inc. with the FDA for Ct Brain Perfusion For Ziostation.
| Device ID | K083084 |
| 510k Number | K083084 |
| Device Name: | CT BRAIN PERFUSION FOR ZIOSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | ZIOSOFT, INC. 2200 BRIDGE PARKWAY, SUITE 103 Redwood City, CA 94065 |
| Contact | Richard Ball |
| Correspondent | Richard Ball ZIOSOFT, INC. 2200 BRIDGE PARKWAY, SUITE 103 Redwood City, CA 94065 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-16 |
| Decision Date | 2008-12-19 |
| Summary: | summary |