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Canon Aplio Diagnostic Ultrasound Systems - HSA Registration DE0507906

Access comprehensive regulatory information for Canon Aplio Diagnostic Ultrasound Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507906 and owned by Canon Medical Systems Corporation. The device was registered on March 15, 2023.

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
DE0507906
Canon Aplio Diagnostic Ultrasound Systems
HSA Registration Number: DE0507906
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Product Description

Indicated for the visualization of structures and dynamic processes within the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, small organs (thyroid, breast and testicle), neonatal cephalic, adult cephalic, trans-rectal, transvaginal, musculo-skeletal (both conventional and superficial), cardiac, peripheral vascular, and thoracic/pleural.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0507906
Registration Date
March 15, 2023
Change Notification Approval Date
June 07, 2024
Retention Due Date
March 14, 2026
Product Owner
Short Name
Canon Medical Systems Corporation
Address
1385 Shimoishigami, Otawara-Shi, Tochigi 324-8550, JAPAN
Registrant
Address
211 HENDERSON ROAD, 211 HENDERSON, #08-02, SINGAPORE 159552
Importer
Address
211 HENDERSON ROAD, 211 HENDERSON, #08-02, SINGAPORE 159552
Model Information
Model Name(s)
Diagnostic Ultrasound System Aplio flex Diagnostic Ultrasound System Aplio go LINEAR ARRAY TRANSDUCER LINEAR ARRAY TRANSDUCER LINEAR ARRAY TRANSDUCER PHASED ARRAY TRANSDUCER PHASED ARRAY TRANSDUCER CONVEX ARRAY TRANSDUCER ENDOCAVITARY TRANSDUCER CONVEX ARRAY TRANSDUCER CONVEX ARRAY TRANSDUCER ENDOCAVITARY TRANSDUCER CONVEX ARRAY TRANSDUCER SONO COUPLER BIOPSY ADAPTOR BIOPSY ADAPTOR APLIGATE KIT ISOLATION TRANS FOR LAN KIT MECHA4D UNIT PALM CONTROLLER KIT RECORDER UNIT 4 PROBE PORT KIT BATTERY UNIT CW KIT EV/ER TRANSDUCER HOLDER KIT PANEL SPACER KIT PANEL SPACER KIT MOUNTING KIT FOR PERIPHERAL UNIT MOUNTING KIT FOR PERIPHERAL UNIT ECG CABLE HANGER KIT REFERENCE SIGNAL UNIT TRANSDUCER CABLE HANGER KIT TRANSDUCER HOLDER KIT VIDEO KIT 21.5W MONITOR KIT WIRELESS LAN KIT REFERENCE SIGNAL CABLE FOOT SWITCH GEL WARMER
Model Identifier(s)
CUS-AFL00 CUS-AGG00 PLC-1004LT PLC-704LT PLU-1204BT PSC-25LT PSU-50BT PVC-375LT PVC-781VLT PVU-382BT PVU-674MVS PVU-681MVL PVU-712BTE UACK-004A UAGV-027A UAGV-035A UHCO-AGATE1 UHCO-ITLAN UHCO-M4D UHCO-PT003A UHCO-REC1 UHFL-4THPO UHFL-BTRY UHFL-CW UHFL-ECHOLD UHFL-OP700S UHFL-OP900S UHFL-PERMAC UHFL-PERMDC UHFL-REFCH UHFL-REFSG UHFL-TCHAN UHFL-THOLD UHFL-VPANE UHGG-MON215 UIWL-AI900A UJUR-AI900A UZFS-004A UZGW-008A