The following data is part of a premarket notification filed by 4dx Limited with the FDA for Xv Lung Ventilation Analysis Software.
| Device ID | K193293 |
| 510k Number | K193293 |
| Device Name: | XV Lung Ventilation Analysis Software |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | 4Dx Limited Level 5 Suite 3, 468 St Kilda Rd Melbourne, AU 3004 |
| Contact | Terrence Thiel |
| Correspondent | Terrence Thiel 4DX Limited Level 5 Suite 3, 468 St Kilda Rd Melbourne, AU 3004 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-27 |
| Decision Date | 2020-05-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 19356870000014 | K193293 | 000 |