Recognition List Number: 027 Publication Date: 08/02/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-227: IEC 61391-1 First edition 2006-07, Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response. (Radiology)
Date of Standard: 2006. |
| Address of Standards Organization: |
| International Electrotechnical Commission (IEC) |
| 3, Rue de Varembe' |
| PO Box 131 |
| CH-1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) |
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| (2) | OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) |
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| Devices Affected: |
| Ultrasonic Pulsed Doppler Imaging Systems, Ultrasonic Pulsed Echo Imaging Systems |
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| Processes Affected: |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
| Complete standard and any annexes, requires addition of device specific information |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.1550 |
System, Imaging, Pulsed Doppler, Ultrasonic |
Class 2 |
IYN |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.1560 |
System, Imaging, Pulsed Echo, Ultrasonic |
Class 2 |
IYO |
| |
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| Relevant Guidance: |
| Guidance for Industry and FDA Staff Information for Manufacterers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Document issued on: September 9, 2008. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM070911.pdf |
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| FDA Technical Contact: |
| Keith Wear |
| FDA/CDRH/OSEL |
| 10903 New Hampshire Avenue Building 62, Room 3108 |
| Silver Spring MD 20993 |
| 301/796-2538 |
| Email: keith.wear@fda.hhs.gov |
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