Device Information
Device Specifications
The Aplio i900, i800, and i700 V8.1 models are mobile diagnostic ultrasound systems with a range of probes. They use frequencies from 2 MHz to 33 MHz, enabling imaging in multiple clinical applications. This system supports high-resolution imaging modes like B mode, Color Doppler, Elastography, and Acoustic attenuation mapping, making it versatile for detailed imaging in hospital and clinical settings.
Indications
The Aplio i900, i800, and i700 systems are designed to visualize structures and dynamic processes within the body. They provide diagnostic images for applications such as abdominal, cardiac (adult and pediatric), and musculoskeletal imaging.
Intended Use
The system is intended for use by trained physicians in hospital and clinical settings or legally qualified healthcare workers. It provides high-quality ultrasound images in multiple modes for diagnosis.
Availability
Prescription only, as specified under 21 CFR 801 Subpart D.
Study Results
- Clinical Testing: Left Atrial Appendage (LAA) Analysis was evaluated using 10 in-vivo cine data. It showed improved workflow compared to manual methods.
- Nonclinical and Safety Testing: Risk analysis and validation activities met established standards like IEC 60601 and ISO 13485. Additional testing confirmed the system’s compliance with safety and performance requirements.
Regulatory Information
- Regulation Number: 21 CFR 892.1550, 21 CFR 892.1560, 21 CFR 892.1570
- Regulatory Class: Class II
- Product Code: IYN, IYO, ITX
- 510(k) Number: K233195
The device must adhere to 21 CFR Parts 820 and 807 regulations for good manufacturing practices and labeling.
Manufacturer Information
- Name: Canon Medical Systems Corporation
- Address: 1385 Shimoishigami, Otawara-shi, Tochigi-ken, Japan 324-8550
- Contact Person: Yoshiaki Cook, Manager, Regulatory Affairs, Canon Medical Systems USA
Predicate Device Information
- Predicate Device: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (K223017), Olympus GF Type UC180, Olympus GF Type UCT180 (K093395)
- Is the Predicate Device an Earlier Version of the Same Device? Yes.
- Differences: The V8.1 version includes additional features such as Left Atrial Appendage Analysis and expanded transducer support.
Implications
The updated system provides enhanced diagnostic capabilities for physicians, especially in cardiac analysis and gastrointestinal imaging. Integrating new software features offers more detailed diagnostic data and improved workflows.
References
- Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System. K233195. Canon Medical Systems Corporation. FDA summary link. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K233195
- https://us.medical.canon/
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