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 |