Lung Density Analysis
by Imbio, LLC
510(k) K141069
Lung Density Analysis is a Class II device made by Imbio, LLC, cleared under FDA 510(k) K141069 on 17 Sep 2014, 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 | NumberK141069 | Date17 Sep 2014 | StatusActive |
Official records
- FDA 510(k) database K141069
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JAK
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K141069
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Imbio Freya 3.2.0 | 3.2.0 | 00850894007667 | On the market | |
| Imbio Freya 3.3.0 | 3.3.0 | 00850894007681 | On the market | |
| Imbio Freya 4.0.1 | 4.0.1 | 00850894007735 | On the market | |
| Imbio Freya 5.0.0 | 5.0.0 | 00850894007780 | On the market | |
| Imbio Freya 5.0.1 | 5.0.1 | 00850894007827 | On the market | |
| Imbio Freya 5.0.2 | 5.0.2 | 00850894007858 | On the market | |
| Imbio LDA 2.4 | 2.4 | 00850894007018 | On the market | |
| Imbio LDA 2.4.1 | 2.4.1 | 00850894007025 | On the market | |
| Imbio LDA 2.4.2 | 2.4.2 | 00850894007032 | On the market | |
| Imbio LDA 2.4.3 | 2.4.3 | 00850894007056 | On the market | |
| Imbio LDA 2.4.4 | 2.4.4 | 00850894007070 | On the market | |
| Imbio LDA 2.4.5 | 2.4.5 | 00850894007094 | On the market | |
| Imbio LDA 2.5.1 | 2.5.1 | 00850894007292 | On the market | |
| Imbio LDA 2.5.2 | 2.5.2 | 00850894007322 | On the market | |
| Imbio LDA 2.7.0 | 2.7.0 | 00850894007414 | On the market | |
| Imbio LDA 2.7.1 | 2.7.1 | 00850894007506 | On the market | |
| Imbio LDA 3.0.0 | 3.0.0 | 00850894007551 | On the market | |
| Imbio LDA 3.0.2 | 3.0.2 | 00850894007575 | On the market | |
| Imbio LDA 3.0.3 | 3.0.3 | 00850894007582 | On the market | |
| Imbio LDA 3.1 | 3.1 | 00850894007599 | On the market | |
| Imbio LDA 3.1.1 | 3.1.1 | 00850894007612 | On the market | |
| Imbio LDA 4.0.0 | 4.0.0 | 00850894007629 | On the market | |
| Imbio LDA 4.1.0 | 4.1.0 | 00850894007674 | On the market | |
| Imbio LDA 5.0.0 | 5.0.0 | 00850894007773 | On the market | |
| Imbio LDA 5.0.1 | 5.0.1 | 00850894007810 | On the market | |
| Imbio LDA 5.0.2 | 5.0.2 | 00850894007841 | On the market | |
| Imbio LDA 5.0.3 | 5.0.3 | 00850894007865 | On the market | |
| Imbio LDA 5.1.0 | 5.1.0 | 00850894007889 | On the market | |
| Imbio LDA 5.1.1 | 5.1.1 | 00850894007926 | On the market | |
| LDA 5.2.x | 5.2.x | 19356870000090 | On the market |
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