# K153480: ClearVue850 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Health Care
- Decided: Dec 16, 2015 after 14 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K935595 (1995). 127 ancestors in all.
2 later devices descend from it; 1 cites it directly.
6 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120321: Clearvue 350/550 Diagnostic Ultrasound System, Philips Health Care (2012) Summary page 5.
- K132304: Epiq Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2013) Summary page 10.

## Most influential descendants
- K163020: Xperius Ultrasound System (2016), 1 descendant of its own
- K182529: Xperius Ultrasound System (2018), 0 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-2403-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2375-2025: 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-2347-2025: 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.
- May 28, 2025 · Class II · Z-2048-2025: 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.
- May 28, 2025 · Class II · Z-2062-2025: Ultrasound transducer devices were refurbished beyond their useful life.

## Indications for use
The ClearVue850 Diagnostic Ultrasound system is a general purpose, portable, cart based ultrasound system, intended for use by customers in various clinical settings (private offices, clinics, small hospitals, large hospitals, primary and community healthcare centers) by different users (General Practitioners, Paraprofessionals, physician specialists including OBG’s, Ultrasound Lab physicians, and nurse practitioners, etc., The 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), 4D and SonoCT, Combined modes includes FloVue, Elastography (strain). 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 Form section 1.3 which includes Fetal / OB, Abdominal,Pediatric,Small Organ (breast, thyroid, testicle),Neonatal Cephalic,Adult Cephalic,Trans-rectal, Trans-vaginal,Musculo-skel. (Conventional), Musculo-skel. (Superficial),Other: GYN,Other: Urology,Cardiac Adult,Cardiac Pediatric,Trans-esophageal (Cardiac),Other (Fetal Echo),Peripheral vessel and Cerebral Vascular.

Source page: https://510kreport.com/device/K153480
Methodology: https://510kreport.com/methodology