| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
064
|
Date of Entry 05/26/2025
|
|
FR Recognition Number
|
12-383
|
| Standard | |
NEMA NU 1-2023
Performance Measurements of Gamma Cameras |
|
Scope/Abstract| This Standards Publication establishes definitions, quantitative measurements of performance characteristics, and reporting techniques for the specification of the following Gamma camera parameters |
|
| Extent of Recognition
|
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| FDA recognition of NEMA NU 1-2018 [Rec# 12-337] will be superseded by recognition of NEMA NU 1-2023 [Rec# 12-383]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-337] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 12-337] will not be accepted. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §892.1100 |
Camera, Scintillation (Gamma)
|
Class 1
|
IYX
|
|
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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
