Singapore HSA registration DE0507016
Boston Scientific Visual-ICE® MRI Cryoablation System
Singapore·CLASS C·Boston Scientific Coporation·Registered June 27, 2022Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0507016
- Registration Date
- June 27, 2022
- Change Notification Approval Date
- March 13, 2025
- Retention Due Date
- June 26, 2026
Product description
The Visual-ICE MRI Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Boston Scientific accessory products are required to perform these procedures.The Visual-ICE MRI Cryoablation System is intended for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology.This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures.
Product Owner
- Short Name
- Boston Scientific Coporation
- Address
- 300 Boston Scientific Way, Marlborough, MA01752-1234, UNITED STATES
Registrant
- Address
- 9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Importer
- Address
- 9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Model information
- Model Name(s)
- Visual-ICE™ MRI Cryoablation Console IceRod™ MRI 1.5 Cryoablation Needle IceRod™ MRI 1.5 Cryoablation Needle IceRod™ MRI 1.5 90° Cryoablation Needle IceRod™ MRI 1.5 90° Cryoablation Needle Visual-ICE™ MRI Junction Box Assembly Visual-ICE™ MRI Mobile Connection Panel Visual-ICE™ MRI Junction Box Harness (5 m) Visual-ICE™ MRI Junction Box Harness (10 m) Visual-ICE™ MRI Junction Box Harness (15 m)
- Model Identifier(s)
- H7493961070000 H7493962831920 H7493962931930 H7493963031940 H7493963131950 H7493969970500 H7493970071000 SPR7005 SPR7010 SPR7015
About this record
Access comprehensive regulatory information for Boston Scientific Visual-ICE® MRI Cryoablation System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0507016 and owned by Boston Scientific Coporation. The device was registered on June 27, 2022.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C