The following data is part of a premarket notification filed by Qi Imaging, Llc with the FDA for Ziostation2.
| Device ID | K151212 |
| 510k Number | K151212 |
| Device Name: | Ziostation2 |
| Classification | System, Image Processing, Radiological |
| Applicant | QI IMAGING, LLC 1235 RADIO ROAD, STE 110 Redwood City, CA 94065 |
| Contact | Richard Ball |
| Correspondent | Richard Ball QI IMAGING, LLC 1301 Shoreway Road, Suite 325 Belmont, CA 94002 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-06 |
| Decision Date | 2015-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04571320222008 | K151212 | 000 |