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Hologic Fluoroscan InSight 2 Mini C-arm Fluoroscopic Imaging System - HSA Registration DE0007708

Access comprehensive regulatory information for Hologic Fluoroscan InSight 2 Mini C-arm Fluoroscopic Imaging 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 DE0007708 and owned by Hologic Inc.. The device was registered on October 04, 2011.

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 C
DE0007708
Hologic Fluoroscan InSight 2 Mini C-arm Fluoroscopic Imaging System
HSA Registration Number: DE0007708
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Product Description

Designed to provide physicians with general fluoroscopic visualization of a patient, including, but not limited to surgical orthopedic and podiatry use, critical and emergency care procedures, and light anatomy imaging situations.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90221200
Registration Information
Registration Number
DE0007708
Registration Date
October 04, 2011
Change Notification Approval Date
September 12, 2024
Retention Due Date
October 03, 2025
Product Owner
Short Name
Hologic Inc.
Address
600 Technology Drive, Newark, DE 19702, UNITED STATES
Registrant
Address
219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556
Importer
Address
219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556
Model Information
Model Name(s)
InSight-Premier Sterile Drape Insight Wireless Networking Infrared wireless foot switch InSight Surgical Mini C-arm Fluoroscopic System InSight-FD (Flat Detector) Mini C-Arm System Unity Extended Connectivity Software Wired 3 pedal foot switch DICOM Store/Send for Insight Insight DICOM Worklist
Model Identifier(s)
110788 INSIGHT-WiFi InSight Wireless Foot Switch Insight 2 Insight FD Insight-DICOM-Unity PRD-00112 PRD-00121 PRD-00122