Taiwan FDA registration 7aa09120069cc0ebd0cf68d114dc7d8f
"Accuray" helical tomotherapy system
TW: “安科銳“螺旋斷層放射治療系統
Taiwan·Risk Class 2·Accuray Incorporated·Registered Apr 19, 2022 – Apr 19, 2027ActiveRegistration details
- Analysis ID
- 7aa09120069cc0ebd0cf68d114dc7d8f
- Customs Code
- DHAS5603540504
Company information
- Manufacturer
- Accuray Incorporated
- Manufacturer Country
- United States
- Authorized Representative
- QUALTECH CONSULTING CORPORATION
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- P Radiology Science
- Product Type (Level 2)
- P.5050 Medical Charged Particle Radiotherapy System
- Import Information
- Consent must be attached to the import (with the consent of the Atomic Energy Commission must be obtained for each import); Input;; The use of this device shall comply with the provisions of the Administrative Measures for the Implementation or Use of Medical Devices for Specific Medical Technology Inspection and Testing.
Dates and status
- Registration Date
- Apr 19, 2022
- Expiry Date
- Apr 19, 2027
About this record
Access comprehensive regulatory information for "Accuray" helical tomotherapy system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7aa09120069cc0ebd0cf68d114dc7d8f and manufactured by Accuray Incorporated. The authorized representative in Taiwan is QUALTECH CONSULTING CORPORATION.
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