# K071156: Sounmed SD-2000 Plus Portable Ultrasound Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Sounmed, Inc.
- Decided: Jul 3, 2007 after 69 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: 1 generation back to K000030 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000030: Sonoace 600 Diagnostic Ultrasound System, Medison America, Inc. (2000) Summary page 1.

## Indications for use
Diagnostic ultrasound imaging or fluid flowd analyisis of the human body as follows: Diagnostic ultrasound imaging or fluid flowd analyisis of the human body as follows: Diagnostic ultrasound imaging or fluid flowd analyisis of the human body as follows: Diagnostic ultrasound imaging or fluid flowd analyisis of the human body as follows:

Source page: https://510kreport.com/device/K071156
Methodology: https://510kreport.com/methodology