# Imbio, LLC

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 6 (2014–2024): 6 510(k) clearances
- Names in FDA's records: Imbio, LLC (3); Imbio, Inc. (3)
- Product codes: QIH (2), JAK (2), LLZ (1), QWO (1)
- 510(k) review time since 2016: median 95 days, against 132 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 6 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Circle Cardiovascular Imaging, Inc.: 1 (https://510kreport.com/company/circle-cardiovascular-imaging)
- Mim Software, Inc.: 1 (https://510kreport.com/company/mim-software)
- Imvaria, Inc.: 1 (https://510kreport.com/company/imvaria)
- Zebra Medical Vision, Ltd.: 1 (https://510kreport.com/company/zebra-medical-vision)

## Firms that cite its devices most
- HeartLung Corporation: 1 (https://510kreport.com/company/heartlung)
- Viz. Ai, Inc.: 1 (https://510kreport.com/company/viz-ai)
- Ever Fortune.Ai, Co., Ltd.: 1 (https://510kreport.com/company/ever-fortune-ai)
- Ai4medimaging Medical Solutions S.A.: 1 (https://510kreport.com/company/ai4medimaging-medical-solutions)
- Ischemaview, Inc.: 1 (https://510kreport.com/company/ischemaview)

## Its most-cited devices
- K203256: Imbio RV/LV Software (2021), cited by 6

## Recent decisions
- K242467: IQ-UIP (Dec 19, 2024)
- K241847: Imbio PHA (4.0.0) (Aug 30, 2024)
- K230112: CAC Software (Jun 13, 2023)
- K203256: Imbio RV/LV Software (Mar 9, 2021)
- K180129: Imbio Segmentation Editing Tool software (Mar 16, 2018)
- K141069: Lung Density Analysis (Sep 17, 2014)

Source page: https://510kreport.com/company/imbio