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Philips ClearVue 850 Ultrasound System - HSA Registration DE0017731

Access comprehensive regulatory information for Philips ClearVue 850 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 DE0017731 and owned by Philips Ultrasound LLC. The device was registered on December 17, 2015.

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
DE0017731
Philips ClearVue 850 Ultrasound System
HSA Registration Number: DE0017731
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Product Description

Philips ClearVue ultrasound systems are intended for diagnostic imaging or for fluid flow analysis of the human body. The system may also be used in biopsy guidance and to assist in infertility monitoring of follicle development (OB). The intended use of the product is to collect ultrasound image data that may be used by clinicians for screening, diagnostic, and procedural purposes include: Abdominal, Cardiac Adult, Cardiac (Fetal), Cardiac Pediatric, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Musculoskeletal (Conventional and Superficial), Pediatric Abdomen, Pediatric Hip, Peripheral Vessel, Peripheral Vessel (Carotid), Small Organ (Breast, Thyroid, Testicle), Small Organ (Prostate), Transrectal and Transvaginal.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0017731
Registration Date
December 17, 2015
Change Notification Approval Date
September 13, 2024
Retention Due Date
December 16, 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)
Non-sterile biopsy bracket  Non-sterile biopsy bracket  Probe Cover  Ultra Pro II Probe Cover  Probe Cover  3-lead ECG leadset AAMI  3-lead ECG leadset IEC  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)  Biopsy guide starter kit, C5-2 reusable  Biopsy guide starter kit, C9-4v disposable  Biopsy guide starter kit, C9-4v reusable  Biopsy guide starter kit, S4-1 disposable  Biopsy guide starter kit, S4-1 reusable  Biopsy guide starter kit, C5-2 disposable  Biopsy guide starter kit, L12-4  Non-sterile biopsy bracket  Non-sterile biopsy bracket  Non-sterile biopsy bracket  Non-sterile biopsy bracket  Non-sterile biopsy bracket  Non-sterile biopsy bracket  Non-sterile biopsy bracket  Non-sterile biopsy bracket  ClearVue 850 Diagnostic Ultrasound System  Biopsy guide starter kit, 3D9-3v  Biopsy guide starter kit, V6-2  Transducer C9-4v  Transducer L12-4  Transducer S4-1  Transducer 3D9-3v  Transducer V6-2  Transducer L12-5  Transducer L12-4 (revision)  Biopsy Kit, L12-5 OPAL  Keyboard Cover  Transducer C5-2  Footswitch
Model Identifier(s)
134-111 134-165 302-215HR 302-365 302-588 453561365771 453561365781 453561490101 453561490111 453561490121 453561490131 453561490141 453561498101 453561498131 453561498141 453561498151 453561498171 453561498681 453561623351 467-033 467-070 467-072 467-074 467-075 467-077 467-080 467-108 795226 989605351091 989605361861 989605389252 989605389261 989605389272 989605415032 989605415042 989605428531 989605430652 989605441611 989605453911 989605454101 SP-515665