| IEC 61391-1 Edition 1.1 2017-07 CONSOLIDATED VERSION Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response |
| Recognition Number | Radiology |
| Recognition Date | 2018-06-07 |
| Recognition List | 049 |
| Recognition Number | 12-312 |
| Extent | Complete standard |
| Standards Orgs | IEC International Electrotechnical Commission http://www.iec.ch/ |
| STG | Radiology |
| FDA Tech | Keith Wear FDA/OMPT/CDRH/OSEL/DAM/ 301-796-2538 keith.wear@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This International Standard describes methods of calibrating the spatial measurement facilities and point-spread function of ultrasonic imaging equipment in the ultrasonic frequency range 0,5 MHz to 15 MHz. This standard is relevant for ultrasonic scanners based on the pulse-echo principle of the types listed below:
- mechanical sector scanners;
- electronic phased-array sector scanners;
- electronic linear-array scanners;
- electronic curved-array sector scanners;
- water-bath scanners based on any of the above four scanning mechanisms;
- 3D-volume reconstruction systems
| Regulation Number | Device Name | Device Class | Product Code |
| §892.1560 | System, Imaging, Pulsed Echo, Ultrasonic | Class 2 | IYO |
| §892.1550 | System, Imaging, Pulsed Doppler, Ultrasonic | Class 2 | IYN |
| Guidance for Industry and FDA Staff: Information for Manufacterers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, Issued September 2008. |