# K120321: Clearvue 350/550 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Health Care
- Decided: Feb 17, 2012 after 15 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K043535 (2005). 1 ancestor in all.
91 later devices descend from it; 3 cite it directly.
2 of 93 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.

## Most influential descendants
- K133833: Nuvis Diagnostic Ultrasound System (2014), 87 descendants of its own
- K152899: Philips Lumify Diagnostic Ultrasound System (2015), 79 descendants of its own
- K162549: Lumify Ultrasound System (2016), 43 descendants of its own
- K192226: Lumify Diagnostic Ultrasound System (2019), 31 descendants of its own
- K163138: Clarius Ultrasound System (2016), 28 descendants of its own

## Recalls of this device
- Sep 5, 2025 · Class III · Z-1625-2026: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2373-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2364-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2391-2025: 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-2050-2025: Ultrasound transducer devices were refurbished beyond their useful life.
- May 28, 2025 · Class II · Z-2055-2025: 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
The ClearVue 350/550 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in the following modes: B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Harmonics, iSCAN, X-Res, angio, 3D (freehand), and SonoCT. The system may also be used in biopsy guidance and to assist in infertility monitoring of follicle development (OB). The system is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications, as listed in FDA's Diagnostic Ultrasound Indications for Use Forms (included in the submittal): Fetal / Obstetric Abdominal Pediatric Small Organ (thyroid, scrotum, prostate, breast) Neonatal Cephalic Adult Cephallic Trans-rectal Trans-vaginal Musculoskeletal (conventional) Musculoskeletal (superficial) Other - Gynecological Cardiac Adult Cardiac Pediatric Cardiac Other - Fetal Peripheral Vessel Peripheral Vessel Other - Carotid The clinical environments where the ClearVue 350/550 Diagnostic Ultrasound System can be used include hospital, clinical and medical office settings for diagnosis of patients. The use models for ClearVue 350/550 are within the scope of and substantially equivalent to current indications for use for Diagnostic Ultrasound System. 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/K120321
Methodology: https://510kreport.com/methodology