Singapore HSA registration DE0509768
Philips Philips 5000 Compact Series Ultrasound Systems
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0509768
- Registration Date
- September 11, 2024
- Change Notification Approval Date
- November 18, 2024
- Retention Due Date
- September 10, 2025
Product description
The intended use of the 5000 Compact series ultrasound systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac Pediatric, Carotid, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal Echo, Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Lung, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Pediatric, Peripheral Vessel, Small Parts, Transesophageal (Cardiac), Transrectal, Transvaginal, and Urology.
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)
- Ultrasound System 5500CV Ultrasound System 5500P Ultrasound System 5500W Ultrasound System 5500G Ultrasound System 5300W Ultrasound System 5300P Ultrasound System 5300G Transducer, S8-3 Transducer, L15-7io Transducer, C9-2 Transducer, C8-5 Transducer, 3D9-3v Transducer, C10-3v Transducer, L18-5 Transducer, C5-1 Transducer, D2cwc Transducer, D5cwc Transducer, L12-3 Transducer, S5-1 Transducer, D2tcd Transducer, X7-2t Transducer, S4-2 Transducer, L12-5 50 Transducer, C9-4v Transducer, C6-2 Transducer, L12-4 Transducer, V6-2 Transducer, X8-2t Transducer, eL18-4 Transducer, L12-3 Ergo
- Model Identifier(s)
- 795141 795143 795144 795145 795146 795147 795148 989605361882 989605387852 989605391092 989605391922 989605395622 989605409562 989605409582 989605412042 989605412052 989605412062 989605412072 989605412082 989605412102 989605414122 989605414692 989605418552 989605418972 989605418983 989605427122 989605437982 989605455171 989605456291 989605492481
About this record
Access comprehensive regulatory information for Philips Philips 5000 Compact Series Ultrasound Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509768 and owned by Philips Ultrasound LLC. The device was registered on September 11, 2024.
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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