FDA-recognized standard · Radiology
IEC 61910-1: Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
Yes. FDA recognizes IEC 61910-1 Edition 1.0 2014-09 as recognition 12-290, entered 2015-08-14.
Recognized editions of IEC 61910-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 12-290 | IEC 61910-1 Edition 1.0 2014-09 | 2015-08-14 | Complete | — |
Regulations
FDA lists these classification regulations against IEC 61910-1: 21 CFR 892.1650, 21 CFR 892.1680, 21 CFR 892.1700, 21 CFR 892.1720.
Product codes that cite IEC 61910-1
7 FDA product codes cite IEC 61910-1, including IZL, IZO, JAA, KPR, MQB.
- IZL System, X-Ray, Mobile
- IZO
- JAA System, X-Ray, Fluoroscopic, Image-Intensified
- KPR System, X-Ray, Stationary
- MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
- OWB Interventional Fluoroscopic X-Ray System
- OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
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.