# K123616: Portable Ultrasonic Diagnostic System

- Pathway: 510(k) (Special)
- Applicant: Sonoscape Company Limited
- Decided: Dec 21, 2012 after 28 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K935595 (1995). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101337: A6 Portable Ultrasonic Diagnostic System, Sonoscape Company Limited (2010) Summary page 2.

## Indications for use
The A6 Portable Ultrasonic Diagnostic System with added transducer is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (Thyroid, parathyroid, parotid, submaxillar, gland, testes and breast.), Peripheral Vascular, Trans-vaginal, Trans-rectal, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, OB/Gyn and Urology. This device is intended to adult, pregnant woman, pediatric, and neonate.

Source page: https://510kreport.com/device/K123616
Methodology: https://510kreport.com/methodology