# Imagen Technologies, Inc.

- Location (FDA's records): New York, NY
- FDA decisions: 6 (2018–2023): 5 510(k) clearances and 1 De Novo grant
- Product codes: MYN (4), QBS (2)
- 510(k) review time since 2016: median 267 days, against 229 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 5 (4 its own); citations of its devices by later devices: 13 (4 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
- Riverain Medical Group,Llc: 1 (https://510kreport.com/company/riverain-medical-group)

## Firms that cite its devices most
- Gleamer: 2 (https://510kreport.com/company/gleamer)
- Icometrix NV: 1 (https://510kreport.com/company/icometrix)
- Qure.Ai Technologies: 1 (https://510kreport.com/company/qure-ai-technologies)
- AZmed: 1 (https://510kreport.com/company/azmed)
- Icad, Inc.: 1 (https://510kreport.com/company/icad)
- Deeptek Medical Imaging Pvt, Ltd.: 1 (https://510kreport.com/company/deeptek-medical-imaging-pvt)
- Screenpoint Medical B.V.: 1 (https://510kreport.com/company/screenpoint-medical)
- Exo, Inc.: 1 (https://510kreport.com/company/exo)

## Its most-cited devices
- K210666: Chest-CAD (2021), cited by 5
- DEN180005: OsteoDetect (2018), cited by 4
- K193417: FractureDetect (FX) (2020), cited by 2
- K213353: Aorta-CAD (2022), cited by 1
- K230085: Lung-CAD (2023), cited by 1

## Recent decisions
- K230085: Lung-CAD (Oct 3, 2023)
- K223811: Lung-CAD (Sep 13, 2023)
- K213353: Aorta-CAD (Sep 20, 2022)
- K210666: Chest-CAD (Jul 20, 2021)
- K193417: FractureDetect (FX) (Jul 30, 2020)
- DEN180005: OsteoDetect (May 24, 2018)

Source page: https://510kreport.com/company/imagen-technologies