FDA-recognized standard · Radiology
IEC 61161: Ultrasonics -- Power measurement -- Radiation force balances and performance requirements
Yes. FDA recognizes IEC 61161 Edition 3.0 2013-01 as recognition 12-275, entered 2014-07-09.
Recognized editions of IEC 61161
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 12-275 | IEC 61161 Edition 3.0 2013-01 | 2014-07-09 | Complete | — |
Regulations
FDA lists these classification regulations against IEC 61161: 21 CFR 870.1200, 21 CFR 878.4410, 21 CFR 890.5300, 21 CFR 890.5860, 21 CFR 892.1570.
Product codes that cite IEC 61161
14 FDA product codes cite IEC 61161, including IMG, IMI, ITX, LNB, LSY.
- IMG
- IMI
- ITX Transducer, Ultrasonic, Diagnostic
- LNB
- LSY
- LXF
- NRB
- NRJ
- NUI
- OBJ Catheter, Ultrasound, Intravascular
- OQQ
- OWQ Reprocessed Intravascular Ultrasound Catheter
- PAA
- PFW
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.