Singapore HSA registration DE0018306
Philips DynaCAD Software
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0018306
- Registration Date
- June 30, 2016
- Change Notification Approval Date
- May 21, 2024
- Retention Due Date
- June 29, 2025
Product description
The DynaCAD software is intended to be used as a post-processing software package designed to provide a reliable means for analyzing MR datasets. DynaLOC Breast Interventional Planning software supports the use of interventional breast coils and MR stereotactic localization devices to perform MR-guided breast interventional procedures. DynaLOC Prostate Interventional is intended to be used by physicians for treatment planning and guidance for clinical, interventional and/or diagnostic procedures of the prostate.
Product Owner
- Short Name
- Philips DS North America LLC
- Address
- 3630 SW 47th Avenue, Gainesville, Florida 32608, 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)
- DynaCAD 5.1 DynaCAD 5 Radiology DynaCAD 5 Urology DynaCAD 5 Radiology DynaCAD 5 Test License DynaCAD Hardware
- Model Identifier(s)
- 3000-103-14352 C-BOM 784043 C-BOM 784044 C-BOM 784045 C-BOM 784046 C-BOM 784048
About this record
Access comprehensive regulatory information for Philips DynaCAD Software in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018306 and owned by Philips DS North America LLC. The device was registered on June 30, 2016.
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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