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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 048 Date of Entry 12/04/2017 
FR Recognition Number 12-307
Standard
AAMI  RT2:2017
Radiation therapy readiness check
Scope/Abstract
AAMI RT2:2017 defines specific patient safety features that can be made available in compliant radiotherapy equipment, if and as applicable to that equipment. It provides a mechanism by which manufacturers can provide information to operators, responsible organizations, and regulators detailing how the specific features of the products that they offer comply with this standard or rationale as to why a specific provision might not apply to a particular product.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.5050 Accelerator, Linear, Medical Class 2 IYE
§892.5050 System, Radiation Therapy, Charged-Particle, Medical Class 2 LHN
§892.5050 System, Planning, Radiation Therapy Treatment Class 2 MUJ
FDA Technical Contacts
 Nancy Wersto
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/NMRTB/
  301-796-6548
  nancy.wersto@fda.hhs.gov
 Amarjeet Bhullar
  FDA/OC/CDRH/OPEQ/OIDRH/DMQS/PMB/
  301-796-5917
  Amarjeet.Bhullar@fda.hhs.gov
Standards Development Organization
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
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