| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
064
|
Date of Entry 05/26/2025
|
|
FR Recognition Number
|
12-377
|
| Standard | |
IEC 62127-03 Edition 2.0 2022-12
Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz |
|
Scope/AbstractThis part of IEC 62127 specifies relevant hydrophone characteristics.
This document is applicable to:
- hydrophones employing piezoelectric sensor elements, designed to measure the pulsed
and continuous wave ultrasonic fields generated by ultrasonic equipment;
- hydrophones used for measurements made in water;
- hydrophones with or without an associated pre-amplifier. |
|
| Extent of Recognition
|
Transition Period
| FDA recognition of IEC 62127-03 Edition 1.1 2013-05 [Rec# 12-279] will be superseded by recognition of IEC 62127-03 Edition 2.0 2022-12 [Rec# 12-377]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-279] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 12-279] will not be accepted. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §892.1550 |
System, Imaging, Pulsed Doppler, Ultrasonic
|
Class 2
|
IYN
|
| §892.1560 |
System, Imaging, Pulsed Echo, Ultrasonic
|
Class 2
|
IYO
|
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. Document issued on: September 9, 2008
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. |
