The following data is part of a premarket notification filed by Qi Imaging, Llc with the FDA for Ct Pulmonary Analysis.
Device ID | K130552 |
510k Number | K130552 |
Device Name: | CT PULMONARY ANALYSIS |
Classification | System, X-ray, Tomography, Computed |
Applicant | QI IMAGING, LLC 1235 RADIO ROAD, STE 110 Redwood City, CA 94065 |
Contact | Richard Ball |
Correspondent | Richard Ball QI IMAGING, LLC 1235 RADIO ROAD, STE 110 Redwood City, CA 94065 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-03-04 |
Decision Date | 2014-01-13 |
Summary: | summary |