# K062247: HD11 Diagnostic Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Philips Ultrasound, Inc.
- Decided: Aug 18, 2006 after 15 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K031066 (2003). 1 ancestor in all.
687 later devices descend from it; 8 cite it directly.
0 of 689 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031066: Viewmate Ultrasound Imaging System, Ep Medsystems (2003) Summary page 5.
- (no number) Philips M2540A EnVisor Ultrasound system: named in the summary without a submission number
- (no number) Philips HDI-5000 series Ultrasound systems: named in the summary without a submission number

## Most influential descendants
- K080935: Sonix MDP Ultrasound Scanner (2008), 584 descendants of its own
- K083095: Sonixtouch Ultrasound System (2008), 582 descendants of its own
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 (2009), 569 descendants of its own
- K110943: Logiq E9 (2011), 472 descendants of its own
- K113690: GE Logiq I, Logiq E and Vivid E (2011), 469 descendants of its own

## Recalls of this device
- Jul 3, 2025 · Class III · Z-2403-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2356-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- May 28, 2025 · Class II · Z-2062-2025: Ultrasound transducer devices were refurbished beyond their useful life.

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

Source page: https://510kreport.com/device/K062247
Methodology: https://510kreport.com/methodology