Lung Vision System
510(k) K183593
Lung Vision System is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Bodyvision Medical, Ltd., cleared under FDA 510(k) K183593 on 18 Apr 2019, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK183593 | Date18 Apr 2019 | StatusActive |
Official records
- FDA 510(k) database K183593
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- FDA applicant
- Bodyvision Medical , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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