# Irvine Biomedical,Inc.(Ibi)

- Location (FDA's records): Irvine, CA
- FDA decisions: 2 (2005–2007): 1 510(k) clearance and 1 original PMA approval
- Product codes: DQO (1), OAD (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Siemens Medical Solutions USA, Inc.: 2 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Acuson Corp.: 1 (https://510kreport.com/company/acuson)

## Recent decisions
- K070011: Ibi Inquiry Clearice Intracardiac Echocardiography Ultrasound Imaging Catheter (Mar 20, 2007)
- P040042: Therapy Dual 8 Cardiac Ablation System,Theram 8MM Thermister Ablation Catheter Safire TX Ablation Catheter (Nov 18, 2005)

Source page: https://510kreport.com/company/irvine-biomedical-ibi