# K102253: Echo Blaster

- Pathway: 510(k) (Traditional)
- Applicant: Telemed
- Decided: Mar 14, 2011 after 217 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: 5 generations back to K944485 (1995). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050551: Voyager Personal Imaging Device, Ardent Sound, Inc. (2005) Summary page 1.
- K060800: Seeker/Spark Ultrasound System, Ardent Sound, Inc. (2006) Summary page 1.
- K003121: Mysono 201 Diagnostic Ultrasound and Transducers, Medison America, Inc. (2000) Summary page 1.

## Most influential descendants
- K161968: MicrUs (2016), 0 descendants of its own

## Indications for use
Echo Blaster 128 1 Echo Blaster 64 ultrasound imaging systems are intended to be used for applications in fetal, abdominal, pediatriq small organ (breast, thyroid and testicles), cephalic (neonatal and adult). musculoskeletal (conventional), musculoskeletal (superficial), cardiac adult and peripheral vessel (including imaging for needle guidance, see chiS.). It is possible to provide diagnostic information (B, B+M and M-mode imaging) outside of an imaging lab, including at the bedside systems, for navigated medical application, inoperating rooms/critical care units.

Source page: https://510kreport.com/device/K102253
Methodology: https://510kreport.com/methodology