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Philips EPIQ Ultrasound System - HSA Registration DE0016402

Access comprehensive regulatory information for Philips EPIQ Ultrasound System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0016402 and owned by Philips Ultrasound LLC. The device was registered on October 13, 2014.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0016402
Philips EPIQ Ultrasound System
HSA Registration Number: DE0016402
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Product Description

Diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: โ€ข Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intra-cardiac Echo, Intra-luminal, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. โ€ข The clinical environments where EPIQ Series Diagnostic Ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. โ€ข When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0016402
Registration Date
October 13, 2014
Change Notification Approval Date
December 13, 2024
Retention Due Date
October 12, 2025
Product Owner
Short Name
Philips Ultrasound LLC
Address
22100 Bothell Everett Highway, Bothell, Washington, 98021-8431, UNITED STATES
Registrant
Address
622 LORONG 1 TOA PAYOH, SINGAPORE 319763
Importer
Address
622 LORONG 1 TOA PAYOH, #L3-NA, SINGAPORE 319763
Model Information
Model Name(s)
Field Generator Stand - Pole Assy PercuNav Tool Connection Unit PercuNav Field Generator Philips PercuNav Accessory Kit for the Adaptive Needle Tracker PercuNav System Control Unit Assembly EPIQ 7 General Imaging EPIQ 7 Cardiovascular EPIQ 7 Women's Healthcare EPIQ 5 General Imaging EPIQ 5 Cardiovascular EPIQ 5 Women's Healthcare EPIQ Elite Diagnostic Ultrasound System S8-3 Transducer S12-4 Transducer Footswitch L15-7io Transducer C9-2 Transducerย  C8-5 Transducer 3D9-3v Transducer X5-1 Transducerย  X7-2 Transducerย  Adult ECG Leads Pediatric ECG Leads S7-3t Transducer XL14-3 Transducer X6-1 Transducerย  C10-3v Transducer L18-5 Transducer VL13-5 Transducer C5-1 Transducerย  D2cwc Transducer D5cwc Transducer L12-3 Transducer S5-1 Transducer D2tcd Transducer C10-4ec Transducer X7-2t Transducer L12-5 50 Transducer Physio Kit Power Battery Pack Philips PercuNav Patient Tracker Philips PercuNav Coaxial Needle Tracker, 13G x 11cm Philips PercuNav Coaxial Needle Tracker, 13G x 16cm Philips PercuNav Coaxial Needle Tracker, 16G x 11cm Philips PercuNav Coaxial Needle Tracker, 17G x 16cm Philips PercuNav Coaxial Needle Tracker, 18G x 8cm Philips PercuNav Coaxial Needle Tracker, 18G x 13cm Philips PercuNav Coaxial Needle Tracker, 20G x 8cm Philips PercuNav Coaxial Needle Tracker, 20G x 13cm Philips PercuNav Coaxial Needle Tracker, 20G x 17cm Philips PercuNav Adaptive Needle Tracker Philips PercuNav Ultrasound Tracker S8-3t Transducer eL18-4 Transducer Philips PercuNav Endocavity Ultrasound Tracker V6-2 Transducer X8-2t Transducer eL18-4 Transducer X8-2ti Transducer V9-2 Transducer S9-2 Transducer mC7-2 Transducer L12-3 ERGO Transducer mc12-3 Transducer X5-1c transducer Transducer mL26-8
Model Identifier(s)
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