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Philips ClearVue 650 Ultrasound System - HSA Registration DE0013487

Access comprehensive regulatory information for Philips ClearVue 650 Ultrasound System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0013487 and owned by Philips Ultrasound LLC. The device was registered on July 26, 2013.

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 B
DE0013487
Philips ClearVue 650 Ultrasound System
HSA Registration Number: DE0013487
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Product Description

The ClearVue 650 Ultrasound Systems are intended for cardiac applications and general imaging and analysis. The cart is ergonomically designed to be both highly mobile and adjustable for a range of users and operating conditions. You can use the system for 2D, 3D, 4D, freehand 3D, anoramic, M-mode, Doppler, and Color imaging. You can also perform Duplex imaging and Triplex imaging depending upon the features included in your version. Generalimaging exam protocols are system options. The system supports a wide range of transducers. The system provides measurement tools, analysis options, and DICOM network capabilities.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181200
Registration Information
Registration Number
DE0013487
Registration Date
July 26, 2013
Change Notification Approval Date
September 13, 2024
Retention Due Date
July 25, 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)
3-lead ECG leadset AAMI 3-lead ECG leadset IEC CV 650 Ultrasound System C5-2 Transducer C9-4v Transducer C9-4v Transducer L12-4 Transducer L12-4 Transducer S4-1 Transducer S4-1 Transducer 3D9-3V Transducer 3D9-3V Transducer V6-2 Transducer V6-2 Transducer Transducer L12-5 Transducer L12-4 (revision) C5-2 Transducer 3-lead ECG leadset grabber AAMI (M1624A) 3-lead ECG leadset grabber IEC (M1626A) 3-lead ECG trunk cable AAMI/IEC (M1669A) 3-lead ECG leadset grabber ICU AAMI (M1671A) 3-lead ECG leadset grabber ICU IEC (M1672)
Model Identifier(s)
453561365771 453561365781 795220 989605389241-c 989605389251-c 989605389252 989605389261 989605389261-c 989605389271-c 989605389272 989605415031-c 989605415032 989605415041-c 989605415042 989605428531 989605430652 989605454101 989803144941 989803144951 989803145071 989803145091 989803145101