The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Lung Nodule Assessment And Comparison Option (lna).
| Device ID | K162484 |
| 510k Number | K162484 |
| Device Name: | Lung Nodule Assessment And Comparison Option (LNA) |
| Classification | System, Image Processing, Radiological |
| Applicant | Philips Medical Systems Nederland B.V. Veenpluis 4-6 5684 Pc Best, NL 3088900 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy Qsite 31 Haavoda St. Binyamina, IL 30500 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-07 |
| Decision Date | 2017-02-23 |
| Summary: | summary |