# K081661: HD15 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, Inc.
- Decided: Jun 24, 2008 after 11 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 25 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K031066 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043535: HD11 Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2005) Summary page 1.
- K062247: HD11 Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2006) Summary page 1.

## Recalls of this device
- Sep 5, 2025 · Class III · Z-1620-2026: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Sep 5, 2025 · Class III · Z-1626-2026: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Sep 5, 2025 · Class III · Z-1624-2026: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2377-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2372-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 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-2378-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2396-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2394-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2376-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2397-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2359-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2358-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2357-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2349-2025: 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.
- Jul 3, 2025 · Class III · Z-2347-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2366-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2353-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- May 28, 2025 · Class II · Z-2048-2025: Ultrasound transducer devices were refurbished beyond their useful life.
- May 28, 2025 · Class II · Z-2050-2025: Ultrasound transducer devices were refurbished beyond their useful life.
- May 28, 2025 · Class II · Z-2054-2025: Ultrasound transducer devices were refurbished beyond their useful life.
- May 28, 2025 · Class II · Z-2062-2025: Ultrasound transducer devices were refurbished beyond their useful life.
- May 28, 2025 · Class II · Z-2059-2025: Ultrasound transducer devices were refurbished beyond their useful life.
- Jun 30, 2023 · Class II · Z-2517-2023: Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage,

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

Source page: https://510kreport.com/device/K081661
Methodology: https://510kreport.com/methodology