| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
043
|
Date of Entry 06/27/2016
|
|
FR Recognition Number
|
12-295
|
| Standard | (Included in ASCA) |
IEC 60601-2-33 Ed. 3.2 b:2015
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
|
Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
| Clause: 201.12.4.101.3. |
|
Transition Period
| FDA recognition of IEC 60601-2-33 Ed. 3.2 b:2015 [Rec# 12-295] will be superseded by recognition of IEC 60601-2-33 Edition 4.0 2022-08 [Rec# 12-347]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-295] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 12-295] will not be accepted. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §892.1000 |
System, Nuclear Magnetic Resonance Imaging
|
Class 2
|
LNH
|
| §892.1000 |
System, Nuclear Magnetic Resonance Spectroscopic
|
Class 2
|
LNI
|
| §892.1000 |
Coil, Magnetic Resonance, Specialty
|
Class 2
|
MOS
|
| §892.1000 |
Mri Disposable Kit
|
Class 2
|
OIM
|
|
Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series
Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices. Document issued on: November 14, 1998
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073817.htm
Guidance for Industry and FDA Staff Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices. Document issued on: July 14, 2003
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 Contacts
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
