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Philips DynaCAD Software - HSA Registration DE0018306

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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CLASS B
DE0018306
Philips DynaCAD Software
HSA Registration Number: DE0018306
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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.

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 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