Edan Instruments, Inc. · Class II · Cleared Feb 20, 2025
| K-number | K250214 |
| Device name | Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88) |
| Applicant | Edan Instruments, Inc. |
| Product code | IYN |
| Device class | Class II |
| Decision date | Feb 20, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.1550 |
The Acclarix AX8 and AX9 Series are diagnostic ultrasound systems intended for use by qualified physicians and allied health professionals in hospitals and clinics. They acquire and display ultrasound data in multiple imaging modes including B-mode, M-mode, Doppler, harmonic imaging, elastography, and contrast imaging across clinical applications such as abdominal, cardiac, obstetric, gynecology, urology, musculoskeletal, and vascular imaging.
The subject devices add new models (AX7, AX75, AX78, AX8 Exp, AX8 Super, AX9 Basic, AX9, AX9 Exp, AX9 Super, AX85, AX88), contrast imaging mode, new transducers (L12-5HQ, L12-4HQ, C5-1XQ, C6-2MQ, P7-3MQ), new needle guide brackets, and software features (Stress Echo, Respiratory Wave, eVocal, eWorks, eLive, eHIP, Auto LVOT-D, Live.VF). Clinical applications now include Thoracic/Pleural and Trans-esophageal Cardiac; intra-operative use was deleted.
IEC 60601-1:2005+A1:2012+A2:2020 (general safety), IEC 60601-1-2:2014+A1:2020 (EMC), IEC 60601-2-37:2007+A1:2015 (ultrasonic diagnostic equipment), IEC 60601-2-18:2009 (endoscopic equipment), and FDA's Marketing Clearance Guidance for Diagnostic Ultrasound Systems and Transducers.
The subject devices share the same intended use and basic technological characteristics as the predicate Acclarix AX8/LX9 Series. Although new models, imaging modes, transducers, and clinical applications were added, each new feature has similar specifications to already-cleared reference devices (Resona I9 for Trans-esophageal Cardiac and Thoracic/Pleural; Carnation series for Auto LVOT-D). Bench testing and software validation demonstrate the devices meet the same consensus standards as the predicate, and the technological differences do not raise new safety or effectiveness concerns.
View the full FDA submission: accessdata.fda.gov