The following data is part of a premarket notification filed by Body Vision Medical Ltd. with the FDA for Lung Vision System.
| Device ID | K183593 |
| 510k Number | K183593 |
| Device Name: | Lung Vision System |
| Classification | System, Image Processing, Radiological |
| Applicant | Body Vision Medical Ltd. 34 Sokolov St. Ramat Hasharon, IL |
| Contact | Dorian Averbuch |
| Correspondent | Paul Dryden Body Vision Medical Ltd. % ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-21 |
| Decision Date | 2019-04-18 |