# Koelis

- Location (FDA's records): La Tronche, FR
- FDA decisions: 7 (2010–2018): 7 510(k) clearances
- Product codes: ITX (3), IYN (2), LLZ (2)
- 510(k) review time since 2016: median 97 days, against 83 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 10 (4 its own); citations of its devices by later devices: 6 (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
- CIVCO Medical Instruments Co., Inc.: 3 (https://510kreport.com/company/civco-medical-instruments)
- GE Healthcare: 2 (https://510kreport.com/company/ge-healthcare)
- Eigen: 1 (https://510kreport.com/company/eigen)

## Firms that cite its devices most
- UC-CARE, Ltd.: 1 (https://510kreport.com/company/uc-care)
- Convergent Life Sciences, Inc.: 1 (https://510kreport.com/company/convergent-life-sciences)

## Its most-cited devices
- K131448: 3D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second Look 3DTRUS Fusion Option (2013), cited by 3
- K160357: Trinity (2016), cited by 1
- K141334: Reusable Guide (2014), cited by 1
- K100793: Urostation 3D Prostate Suite (2010), cited by 1

## Recent decisions
- K180970: Disposable guides KDNG00 (Jul 10, 2018)
- K171040: Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range (Jul 31, 2017)
- K170521: Trinity/3D Prostate Suite (May 30, 2017)
- K160357: Trinity (May 2, 2016)
- K141334: Reusable Guide (Jul 11, 2014)
- K131448: 3D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second Look 3DTRUS Fusion Option (Jul 26, 2013)
- K100793: Urostation 3D Prostate Suite (Sep 22, 2010)

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