# K122009: Aida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Panasonic Healthcare Co., Ltd.
- Decided: Oct 3, 2012 after 86 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K894632 (1989). 93 ancestors in all.
No later device cites it as a predicate yet.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113612: Aida V1.5 Diagnostic Ultrasound System GM-72P00A, Panasonic Healthcare Co., Ltd. (2012) Summary page 1.
- K093171: Viamo  Ssa-640A Version 1.2, Toshiba America Medical Systems, In.C (2009) Summary page 1.

## Indications for use
The AIDA V1.8 Diagnostic Ultrasound System GM-72P00A is intended for Peripheral Vessel application. The system provides ultrasound imaging information such as the visualization of anatomical structures, characteristics and dynamic processes within the human body using ultrasound to aid diagnosis. The AIDA V1.8 Diagnostic Ultrasound System GM-72P00A also provides an automated intima-media thickness measurement of peripheral vessels such as the common carotid in the BIMT-modeof operation for heart rate range of 20-150 beats per minute. This system is contraindicated for fetal use.

Source page: https://510kreport.com/device/K122009
Methodology: https://510kreport.com/methodology