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510(k) Data Aggregation
K Number
K152899Device Name
Philips Lumify Diagnostic Ultrasound System
Manufacturer
PHILIPS HEALTHCARE, INC.
Date Cleared
2015-10-30
(29 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS HEALTHCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, and Combined (B + Color) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
- Fetal/Obstetric Abdominal Urology Gynecological Cardiac Fetal Echo Small Organ Musculo-skeletal Peripheral Vessel Carotid
Lumify is intended for use in environments where bealthcare is provided by healthcare professionals, with the exception of home, ambulance, or air.
Device Description
Lumify with the L12-4 transducer is a mobile, general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. Lumify supports wireless network connectivity to allow the user to export ultrasound images.
The Lumify Diagnostic Ultrasound System includes:
- o A commercial off-the-shelf Android device (COTS)
- o Philips ultrasound software running as an app on the off-the-shelf device
- o The C5-2 Curved linear array USB transducer
- o The L12-4 Linear array USB transducer
Eumify provides customers with a smaller, lower cost, and more easily leveraged ultrasound system.
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