AIDA V1.5 Diagnostic Ultrasound System GM-72P00A
by Panasonic Healthcare Co., Ltd.
510(k) K113612
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK113612 | Date10 Feb 2012 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IYN
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1550
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A is a portable diagnostic ultrasound device designed for vascular imaging. It specializes in non-invasive assessment of peripheral vessels, including automated intima-media thickness (IMT) measurement of arteries such as the common carotid. The system incorporates real-time Brightness and Color Doppler imaging to evaluate arterial plaques, supporting cardiovascular diagnostics.
This device is intended for clinical use in diagnostic settings and is supplied as a reusable medical instrument. It operates within a heart rate range of 20–150 beats per minute for IMT measurements and has received FDA 510(k) clearance under the Radiology advisory committee. The system is classified under product code IYN and is authorized for distribution in the United States. No specific sterility or MRI safety information is provided in the available data.
Other devices from Panasonic Healthcare Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the AIDA V1.5 Diagnostic Ultrasound System GM-72P00A used for?
The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A is specifically designed for vascular imaging, enabling non-invasive assessment of peripheral vessels. It features automated intima-media thickness (IMT) measurement of arteries like the common carotid, as well as real-time Brightness and Color Doppler imaging to evaluate arterial plaques. This supports cardiovascular diagnostics by providing detailed visualization of blood flow and vessel structure.
Is the AIDA V1.5 GM-72P00A a single-use or reusable device?
The AIDA V1.5 GM-72P00A is supplied as a reusable medical instrument. Unlike single-use devices, it is intended for repeated clinical use after proper cleaning, maintenance, and sterilization procedures. Reusability ensures cost-effectiveness and consistent performance over time, provided it is handled according to manufacturer guidelines.
What imaging capabilities does this ultrasound system offer?
This system combines Brightness (B-mode) and Color Doppler imaging to provide real-time visualization of blood flow and vessel structure. The automated IMT measurement function allows for precise assessment of arterial walls, particularly in the common carotid artery, while the Doppler capability helps evaluate arterial plaques and overall vascular health.
What heart rate range is supported for IMT measurements?
The AIDA V1.5 GM-72P00A is optimized for IMT measurements within a heart rate range of 20–150 beats per minute. This broad range ensures compatibility with a wide variety of patients, from those with bradycardia to those with tachycardia, making it versatile for clinical use in diverse settings.
How is the regulatory status of this device determined?
The AIDA V1.5 GM-72P00A received FDA 510(k) clearance under the Radiology advisory committee, classified under product code IYN. This means the device was determined to be substantially equivalent to a legally marketed predicate device, fulfilling regulatory requirements for safety and effectiveness in the United States. The clearance process involved review by the Radiology Advisory Committee (RA) and was finalized in February 2012.