Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 052 Date of Entry 07/15/2019 
FR Recognition Number 12-326
Standard
NEMA  NU 2-2018
Performance Measurements of Positron Emission Tomographs
Scope/Abstract
The philosophy and rationale of the standards measurements and illustrative examples of the analysis and results are presented in

Journal of Nuclear Medicine, vol. 43, no. 10, 2002. Daube-Witherspoon ME, Karp JS, Casey ME, DiFilippo FP, Hines H, Muehllehner G, Simcic V, Stearns CW, Adam L-E, Kohlmyer S and Sossi V. "PET Performance Measurements Using the NEMA NU 2-2001 Standard." pp. 1398-1409.

With the exceptions of Section 8 for time-of-flight systems and Section 9 for hybrid PET/CT systems, the Task Force has attempted to specify methods that can be performed on all positron emission tomographs. These include single and multiple slice, discrete and continuous detector, time-of-flight instruments, multi-planar and volume reconstruction models, and dedicated positron emission tomographs as well as other coincidence-capable imaging systems. Wherever possible, future developments that could be readily anticipated were taken into account.
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.
Transition Period
FDA recognition of NEMA NU 2-2018 [Rec# 12-326] will be superseded by recognition of NEMA NU 2-2024 [Rec# 12-382]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-326] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 12-326] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.1100 Scintillation (gamma) camera.
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Daniel Krainak
  FDA/OC/CDRH/OPEQ/OHTVIIIC/
  301-796-0478
  Daniel.Krainak@fda.hhs.gov
Standards Development Organization
NEMA National Electrical Manufacturers Association https://www.nema.org/
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
-
-