# K101337: A6 Portable Ultrasonic Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: Sonoscape Company Limited
- Decided: Sep 30, 2010 after 141 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: 10 generations back to K935595 (1995). 41 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070526: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2007) Summary page 1.
- K041455: Ssi-600/Ssi-800 Diagnostic Ultrasound Imaging System, Sonoscape Company Limited (2004) Summary page 1.
- K052042: Sonoscape Ssi-1000/Ssi-5000 Ultrasound Transducers, Sonoscape Company Limited (2005) Summary page 1.

## Most influential descendants
- K123616: Portable Ultrasonic Diagnostic System (2012), 0 descendants of its own

## 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, submaxillary gland, testes and breast), Peripheral Vascular, Transvaginal, Transrectal, 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/K101337
Methodology: https://510kreport.com/methodology