The following data is part of a premarket notification filed by Pulmonx Corporation with the FDA for Lung Image Analysis.
| Device ID | K212494 |
| 510k Number | K212494 |
| Device Name: | Lung Image Analysis |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Pulmonx Corporation 700 Chesapeake Drive Redwood City, CA 94063 |
| Contact | Terry Solomon |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-08-09 |
| Decision Date | 2021-09-02 |