Singapore HSA registration DE0017731
Philips ClearVue 850 Ultrasound System
Singapore·CLASS B·Philips Ultrasound LLC·Registered December 17, 2015Device 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 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.
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
About this record
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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