Lung Density Analysis
FDA 510(k) K141069 · Imbio, LLC
510(k) numberK141069
Submission
- Device name
- Lung Density Analysis
- Applicant
- Imbio, LLC
Minneapolis, MN, US - Received
- April 24, 2014
- Decision date
- September 17, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JAK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253836 | FCT iStream Phase 2JAK · Traditional | Fujifilm Corporation | 09/04/2026SE |
| K253450 | BodyTom Elite (NL4000)JAK · Traditional | NeuroLogica Corp., a Samsung Company | 07/28/2026SE |
| K253770 | CardIQ SuiteJAK · Traditional | GE Medical Systems SCS | 07/21/2026SE |
| K253560 | Enhanced Boundary for PCCTJAK · Traditional | Ge Medical Systems, LLC | 06/24/2026SE |
| K253026 | Respiratory Gating for Scanners (2.1)JAK · Traditional | Varian Medical Systems, Inc. | 06/04/2026SE |
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK · Traditional | Canon Medical Systems Corporation | 05/20/2026SE |
| K253649 | Spectral CT Verida FamilyJAK · Traditional | Philips Medical Systems Technologies , Ltd. | 03/27/2026SE |
| K253686 | True Definition DLJAK · Traditional | Ge Healthcare Japan Corporation | 03/23/2026SE |
| K252992 | CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 03/23/2026SE |
| K253574 | SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional | Siemens Medical Solutions USA, Inc. | 03/20/2026SE |
More from Siemens Medical Solutions USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K242467 | Iq-UipQWO · Traditional | 12/19/2024SE |
| K241847 | Imbio PHA (4.0.0)QIH · Special | 08/30/2024SE |
| K230112 | CAC SoftwareJAK · Traditional | 06/13/2023SE |
| K203256 | Imbio RV/LV SoftwareQIH · Traditional | 03/09/2021SE |
| K180129 | Imbio Segmentation Editing Tool softwareLLZ · Traditional | 03/16/2018SE |
Questions and answers
When was Lung Density Analysis cleared by the FDA?
Lung Density Analysis (K141069) received a 510(k) decision of Substantially Equivalent on September 17, 2014, 146 days after the submission was received.
What is the product code of K141069?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.