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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 026 Date of Recognition 03/14/2011 
FR Recognition Number 12-221
Standard
IEC 61223-3-4 First edition 2000-03
Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray
Scope/Abstract
This part of IEC 61223 applies to those components of dental X-RAY EQUIPMENT using radiographic imaging systems which influence the image quality and PATIENT dose.

This standard applies to the performance of the ACCEPTANCE TEST on dental X-RAY EQUIPMENT with intra-oral X-RAY IMAGE RECEPTOR and dental X-RAY EQUIPMENT with extra-oral X-RAY IMAGE RECEPTOR (for example, dental panoramic X-RAY EQUIPMENT or cephalometric X-RAY).

This standard applies to dental film and digital image acquisition and processing.

Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§872.1810 Unit, X-Ray, Intraoral Class 2 EAP
§872.1800 System, X-Ray, Extraoral Source, Digital Class 2 MUH
§872.1800 Unit, X-Ray, Extraoral With Timer Class 2 EHD
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contacts
 William Jung
  FDA/OMPT/CDRH/OIR/DRH/NMRT/
  301-796-6228
  william.jung@fda.hhs.gov
 Michael Mendelson
  FDA/OMPT/CDRH/ODE/DAGID/DEDB/
  301-796-6280
  michael.mendelson@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Radiology
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