# K083824: Humanscan M5S-D  Ultrasound Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Humanscan Company, Ltd.
- Decided: Feb 10, 2009 after 50 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GE Vivid E9 M5S-D transducer: named in the summary without a submission number

## Indications for use
The Humanscan M5S-D is phased array ultrasound transducer, for the GE Vivid E9 Ultrasound System, and indicated primarily for ultrasonic evaluation of cardiology conditions. It is also indicated for evaluation of fetal/obstetrics, abdominal, pediatric, adult cephalic, and urology/prostate use.

Source page: https://510kreport.com/device/K083824
Methodology: https://510kreport.com/methodology