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 |